NCT01275677
Version 907 to 908 · National Cancer Institute (NCI)
Patch inspector
Manual review pending.
enrollment_count_change [
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Percentage of Patients Alive and Free From Invasive Disease (IDFS)
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Time to local, regional, or distant recurrence, second non-breast primary breast cancer, or death from any cause, assessed up to 10 years
5 years
/protocolSection/outcomesModule/primaryOutcomes/0/description primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.
/protocolSection/designModule/enrollmentInfo/count enrollment_count_change Enrollment count changes can signal scope or feasibility shifts. 3220
3270
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Percentage of Patients Alive and Disease-Free (DFS-DCIS)
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5 years
/protocolSection/outcomesModule/secondaryOutcomes/0/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Percentage of patients free from a disease-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.
/protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. BCFS
Percentage of Patients Alive and Free From Breast Cancer (BCFS)
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5 years
/protocolSection/outcomesModule/secondaryOutcomes/1/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Percentage of patients free from a breast cancer-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any cause.
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Percentage of Patients Alive and Recurrence-Free (RFI)
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/protocolSection/outcomesModule/secondaryOutcomes/2/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Percentage of patients free from a recurrence-free interval event where events include invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes).
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Percentage of Patients Alive and Free From Distant Recurrence (DRFI)
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/protocolSection/outcomesModule/secondaryOutcomes/3/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Percentage of patients free from a distant recurrence-free interval event where events include distant recurrence or death from breast cancer (censored for deaths from other causes), regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancer.
/protocolSection/outcomesModule/secondaryOutcomes/4/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. OS
Percentage of Patients Alive (Overall Survival)
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Toxicity Assessed by Adverse Events
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Percentage of patients who ever experienced grade 2 or higher toxicites.
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While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose.
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Change in HER2 mRNA Level
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Fcgamma Receptor Polymorphism
/protocolSection/statusModule/statusVerifiedDate 2019-05
2020-09
/protocolSection/statusModule/lastUpdateSubmitDate 2019-05-01
2020-09-01
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2019-05-03
2020-09-23
/protocolSection/statusModule/resultsFirstSubmitDate 2020-05-06
/protocolSection/statusModule/resultsFirstSubmitQcDate 2020-09-01
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"date": "2020-09-23",
"type": "ACTUAL"
} /protocolSection/descriptionModule/briefSummary This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer.
This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with HER2-low invasive breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating HER2-low breast cancer.
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"date": "2020-05-06",
"type": "RELEASE"
},
{
"date": "2020-05-29",
"type": "RESET"
},
{
"date": "2020-07-09",
"type": "RELEASE"
},
{
"date": "2020-07-31",
"type": "RESET"
}
],
"unpostedResponsibleParty": "National Cancer Institute (NCI)"
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} /documentSection/largeDocumentModule/largeDocs/0/date 2011-01-18
2018-02-08
/hasResults false
true
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"pointOfContact": {
"email": "langerj@nrgoncology.org",
"phone": "412-339-5300",
"title": "Director, Department of Regulatory Affairs",
"organization": "NRG Oncology"
},
"certainAgreement": {
"restrictionType": "LTE60",
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose.",
"description": "B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.\nThe total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted.\nThe at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).",
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{
"id": "EG000",
"title": "Arm I (Chemotherapy)",
"description": "Arm I (chemotherapy)",
"otherNumAtRisk": 1615,
"deathsNumAtRisk": 1622,
"otherNumAffected": 1362,
"seriousNumAtRisk": 1615,
"deathsNumAffected": 48,
"seriousNumAffected": 31
},
{
"id": "EG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "Arm II (chemotherapy, trastuzumab)",
"otherNumAtRisk": 1625,
"deathsNumAtRisk": 1628,
"otherNumAffected": 1418,
"seriousNumAtRisk": 1625,
"deathsNumAffected": 61,
"seriousNumAffected": 96
}
],
"otherEvents": [
{
"term": "Alopecia",
"stats": [
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"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 633
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 653
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Anemia",
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"groupId": "EG000",
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},
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"numAffected": 327
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Arthralgia",
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],
"organSystem": "Musculoskeletal and connective tissue disorders",
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},
{
"term": "Bone pain",
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},
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],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Constipation",
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},
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],
"organSystem": "Gastrointestinal disorders",
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},
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"term": "Cough",
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"term": "Diarrhea",
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],
"organSystem": "Gastrointestinal disorders",
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},
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"term": "Fatigue",
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],
"organSystem": "General disorders",
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"organSystem": "Nervous system disorders",
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"term": "Hypertension",
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}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Insomnia",
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}
],
"organSystem": "Psychiatric disorders",
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},
{
"term": "Lymphocyte count decreased",
"stats": [
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"groupId": "EG000",
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},
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}
],
"organSystem": "Investigations",
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},
{
"term": "Mucositis oral",
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"groupId": "EG000",
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"numAffected": 240
},
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}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Myalgia",
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"term": "Nausea",
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}
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},
{
"term": "Neutrophil count decreased",
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},
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}
],
"organSystem": "Investigations",
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},
{
"term": "Peripheral sensory neuropathy",
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"numAffected": 279
},
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"groupId": "EG001",
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}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Upper respiratory infection",
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}
],
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},
{
"term": "Vomiting",
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},
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"numAffected": 129
}
],
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},
{
"term": "White blood cell decreased",
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},
{
"groupId": "EG001",
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}
],
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},
{
"term": "Ejection fraction decreased",
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"groupId": "EG000",
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"numAffected": 164
}
],
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}
],
"seriousEvents": [
{
"term": "Adult respiratory distress syndrome",
"stats": [
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"groupId": "EG000",
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"numAffected": 0
},
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"groupId": "EG001",
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}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Alanine aminotransferase increased (ALT/SGPT)",
"stats": [
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"groupId": "EG000",
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"numAffected": 0
},
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}
],
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},
{
"term": "Aspartate aminotransferase increased (AST/SGOT)",
"stats": [
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"groupId": "EG000",
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},
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}
],
"organSystem": "Investigations",
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},
{
"term": "Asystole",
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"groupId": "EG000",
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"numAffected": 0
},
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}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Blood and lymphatic system disorders - Other, specify",
"stats": [
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"groupId": "EG000",
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},
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}
],
"organSystem": "Blood and lymphatic system disorders",
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},
{
"term": "Catheter related infection",
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{
"groupId": "EG000",
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},
{
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}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Colonic perforation",
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{
"groupId": "EG000",
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"numAffected": 1
},
{
"groupId": "EG001",
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"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Delirium",
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{
"groupId": "EG000",
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"numAffected": 1
},
{
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"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
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},
{
"term": "Depression",
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{
"groupId": "EG000",
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},
{
"groupId": "EG001",
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}
],
"organSystem": "Psychiatric disorders",
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},
{
"term": "Diarrhea",
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},
{
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}
],
"organSystem": "Gastrointestinal disorders",
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},
{
"term": "Disseminated intravascular coagulation",
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{
"groupId": "EG000",
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},
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}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Dyspnea",
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{
"groupId": "EG000",
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"numAffected": 0
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}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Erythema multiforme",
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}
],
"organSystem": "Skin and subcutaneous tissue disorders",
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},
{
"term": "Heart failure",
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{
"groupId": "EG000",
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},
{
"groupId": "EG001",
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"numAffected": 18
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
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},
{
"term": "Hepatic failure",
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},
{
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],
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},
{
"term": "Hepatitis viral",
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],
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},
{
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],
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},
{
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],
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},
{
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},
{
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],
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},
{
"term": "Hyperuricemia",
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},
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},
{
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],
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},
{
"term": "Hypokalemia",
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{
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],
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},
{
"term": "Hypomagnesemia",
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],
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},
{
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},
{
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],
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},
{
"term": "Hypotension",
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}
],
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},
{
"term": "Hypoxia",
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},
{
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],
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},
{
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{
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}
],
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},
{
"term": "Intracranial hemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
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}
],
"organSystem": "Nervous system disorders",
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},
{
"term": "Lipase increased",
"stats": [
{
"groupId": "EG000",
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"numAffected": 1
},
{
"groupId": "EG001",
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}
],
"organSystem": "Investigations",
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},
{
"term": "Multi-organ failure",
"stats": [
{
"groupId": "EG000",
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},
{
"groupId": "EG001",
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}
],
"organSystem": "General disorders",
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},
{
"term": "Myelodysplastic syndrome",
"stats": [
{
"groupId": "EG000",
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"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Myocardial infarction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 2
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Pericardial effusion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Pneumonitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 7
},
{
"groupId": "EG001",
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"numAffected": 5
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Pneumothorax",
"stats": [
{
"groupId": "EG000",
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"numAffected": 0
},
{
"groupId": "EG001",
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}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Pregnancy, puerperium and perinatal conditions - Other, specify",
"stats": [
{
"groupId": "EG000",
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"numAffected": 0
},
{
"groupId": "EG001",
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}
],
"organSystem": "Pregnancy, puerperium and perinatal conditions",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Psychosis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
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"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Respiratory failure",
"stats": [
{
"groupId": "EG000",
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"numAffected": 1
},
{
"groupId": "EG001",
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}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
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"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Sepsis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 7
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Stroke",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Suicide attempt",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Supraventricular tachycardia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 3
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Syncope",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 2
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Thromboembolic event",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Typhlitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Vaginal dryness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Ventricular tachycardia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Leukemia secondary to oncology chemotherapy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Ejection fraction decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 10
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Acute coronary syndrome",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Upper gastrointestinal hemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Enterocolitis infectious",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 2
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Lung infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Tricuspid valve disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Mitral valve disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Aortic valve disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Vascular access complication",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Small intestine infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Acute kidney injury",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Left ventricular systolic dysfunction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 29
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Percentage of Patients Alive and Free From Invasive Disease (IDFS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "89.2",
"groupId": "OG000"
},
{
"value": "89.8",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive and Disease-Free (DFS-DCIS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "89.1",
"groupId": "OG000"
},
{
"value": "89.6",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from a disease-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow-up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive and Free From Breast Cancer (BCFS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "91.0",
"groupId": "OG000"
},
{
"value": "90.7",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from a breast cancer-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any cause.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive and Recurrence-Free (RFI)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "92.3",
"groupId": "OG000"
},
{
"value": "92.0",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from a recurrence-free interval event where events include invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes).",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow-up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive and Free From Distant Recurrence (DRFI)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "93.6",
"groupId": "OG000"
},
{
"value": "92.7",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from a distant recurrence-free interval event where events include distant recurrence or death from breast cancer (censored for deaths from other causes), regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancer.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow-up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive (Overall Survival)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1603",
"groupId": "OG000"
},
{
"value": "1602",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "96.3",
"groupId": "OG000"
},
{
"value": "94.8",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients alive.",
"unitOfMeasure": "percentage of patients alive",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with follow-up"
},
{
"type": "SECONDARY",
"title": "Toxicity Assessed by Adverse Events",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1615",
"groupId": "OG000"
},
{
"value": "1625",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "90.9",
"groupId": "OG000"
},
{
"value": "94.1",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose.",
"description": "Percentage of patients who ever experienced grade 2 or higher toxicites.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow-up."
},
{
"type": "SECONDARY",
"title": "Change in HER2 mRNA Level",
"timeFrame": "From baseline to 24 months",
"description": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy.",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants",
"anticipatedPostingDate": "2022-01"
},
{
"type": "SECONDARY",
"title": "Fcgamma Receptor Polymorphism",
"timeFrame": "From baseline to up to 24 months",
"description": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions.",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants",
"anticipatedPostingDate": "2022-01"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "FG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1630"
},
{
"groupId": "FG001",
"numSubjects": "1640"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1602"
},
{
"groupId": "FG001",
"numSubjects": "1598"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "28"
},
{
"groupId": "FG001",
"numSubjects": "42"
}
]
}
],
"dropWithdraws": [
{
"type": "Not at risk for recurrence.",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "No follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "26"
},
{
"groupId": "FG001",
"numSubjects": "37"
}
]
},
{
"type": "No clinical follow up.",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "4"
}
]
}
]
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1630",
"groupId": "BG000"
},
{
"value": "1640",
"groupId": "BG001"
},
{
"value": "3270",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Arm I (Chemotherapy)",
"description": "Arm I (chemotherapy)"
},
{
"id": "BG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "Arm II (chemotherapy, trastuzumab)"
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "52",
"spread": "10.4",
"groupId": "BG000"
},
{
"value": "52",
"spread": "10.4",
"groupId": "BG001"
},
{
"value": "52",
"spread": "10.4",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "1630",
"groupId": "BG000"
},
{
"value": "1640",
"groupId": "BG001"
},
{
"value": "3270",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "American Indian or Alaska Native",
"measurements": [
{
"value": "8",
"groupId": "BG000"
},
{
"value": "6",
"groupId": "BG001"
},
{
"value": "14",
"groupId": "BG002"
}
]
},
{
"title": "Asian",
"measurements": [
{
"value": "63",
"groupId": "BG000"
},
{
"value": "61",
"groupId": "BG001"
},
{
"value": "124",
"groupId": "BG002"
}
]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
"measurements": [
{
"value": "4",
"groupId": "BG000"
},
{
"value": "7",
"groupId": "BG001"
},
{
"value": "11",
"groupId": "BG002"
}
]
},
{
"title": "Black or African American",
"measurements": [
{
"value": "144",
"groupId": "BG000"
},
{
"value": "175",
"groupId": "BG001"
},
{
"value": "319",
"groupId": "BG002"
}
]
},
{
"title": "White",
"measurements": [
{
"value": "1370",
"groupId": "BG000"
},
{
"value": "1354",
"groupId": "BG001"
},
{
"value": "2724",
"groupId": "BG002"
}
]
},
{
"title": "More than one race",
"measurements": [
{
"value": "9",
"groupId": "BG000"
},
{
"value": "10",
"groupId": "BG001"
},
{
"value": "19",
"groupId": "BG002"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "32",
"groupId": "BG000"
},
{
"value": "27",
"groupId": "BG001"
},
{
"value": "59",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "Mutually exclusive and exhaustive",
"categories": [
{
"title": "Hispanic or Latino",
"measurements": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "106",
"groupId": "BG001"
},
{
"value": "208",
"groupId": "BG002"
}
]
},
{
"title": "Not Hispanic or Latino",
"measurements": [
{
"value": "1488",
"groupId": "BG000"
},
{
"value": "1513",
"groupId": "BG001"
},
{
"value": "3001",
"groupId": "BG002"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "40",
"groupId": "BG000"
},
{
"value": "21",
"groupId": "BG001"
},
{
"value": "61",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
}
]
}
} [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2020-09"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2020-09-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2020-09-23"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2020-05-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2020-09-01"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2020-09-23",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/briefSummary",
"value": "This randomized phase III clinical trial studies chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with HER2-low invasive breast cancer.\nDrugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.\nGiving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells.\nMonoclonal antibodies, such as trastuzumab, can block cancer growth in different ways.\nSome block the ability of tumor cells to grow and spread.\nOthers find tumor cells and help kill them or carry tumor-killing substances to them.\nIt is not yet known whether combination chemotherapy is more effective with trastuzumab in treating HER2-low breast cancer."
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 3270
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Percentage of Patients Alive and Free From Invasive Disease (IDFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Percentage of Patients Alive and Disease-Free (DFS-DCIS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Percentage of patients free from a disease-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Percentage of Patients Alive and Free From Breast Cancer (BCFS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Percentage of patients free from a breast cancer-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any cause."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Percentage of Patients Alive and Recurrence-Free (RFI)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Percentage of patients free from a recurrence-free interval event where events include invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Percentage of Patients Alive and Free From Distant Recurrence (DRFI)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "Percentage of patients free from a distant recurrence-free interval event where events include distant recurrence or death from breast cancer (censored for deaths from other causes), regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancer."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Percentage of Patients Alive (Overall Survival)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Percentage of patients alive."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Toxicity Assessed by Adverse Events"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "Percentage of patients who ever experienced grade 2 or higher toxicites."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Change in HER2 mRNA Level"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
"value": "Fcgamma Receptor Polymorphism"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/documentSection/largeDocumentModule/largeDocs/0/date",
"value": "2018-02-08"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "langerj@nrgoncology.org",
"phone": "412-339-5300",
"title": "Director, Department of Regulatory Affairs",
"organization": "NRG Oncology"
},
"certainAgreement": {
"restrictionType": "LTE60",
"piSponsorEmployee": false,
"restrictiveAgreement": true
}
},
"adverseEventsModule": {
"timeFrame": "All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose.",
"description": "B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.\nThe total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted.\nThe at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).",
"eventGroups": [
{
"id": "EG000",
"title": "Arm I (Chemotherapy)",
"description": "Arm I (chemotherapy)",
"otherNumAtRisk": 1615,
"deathsNumAtRisk": 1622,
"otherNumAffected": 1362,
"seriousNumAtRisk": 1615,
"deathsNumAffected": 48,
"seriousNumAffected": 31
},
{
"id": "EG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "Arm II (chemotherapy, trastuzumab)",
"otherNumAtRisk": 1625,
"deathsNumAtRisk": 1628,
"otherNumAffected": 1418,
"seriousNumAtRisk": 1625,
"deathsNumAffected": 61,
"seriousNumAffected": 96
}
],
"otherEvents": [
{
"term": "Alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 633
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 653
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Anemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 222
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 327
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 161
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 233
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Bone pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 228
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 221
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 135
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 124
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 80
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 136
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 228
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 324
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 629
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 644
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 164
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 187
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypertension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 103
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 196
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Insomnia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 108
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 128
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Lymphocyte count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 131
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 152
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Mucositis oral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 240
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 238
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Myalgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 196
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 222
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 408
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 377
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Neutrophil count decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 145
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 166
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Peripheral sensory neuropathy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 279
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 321
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Upper respiratory infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 78
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 133
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 141
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 129
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "White blood cell decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 119
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 151
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Ejection fraction decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 164
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
}
],
"seriousEvents": [
{
"term": "Adult respiratory distress syndrome",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Alanine aminotransferase increased (ALT/SGPT)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Aspartate aminotransferase increased (AST/SGOT)",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Asystole",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Blood and lymphatic system disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Catheter related infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Colonic perforation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Delirium",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Depression",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 4
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Disseminated intravascular coagulation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Dyspnea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Erythema multiforme",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Heart failure",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 18
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hepatic failure",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Hepatobiliary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hepatitis viral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypercalcemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hyperglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 4
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypertension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 2
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypertriglyceridemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hyperuricemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypocalcemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypokalemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 6
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypomagnesemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
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"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hyponatremia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypotension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Hypoxia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Injury, poisoning and procedural complications - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
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"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Intracranial hemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Lipase increased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Multi-organ failure",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Myelodysplastic syndrome",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Myocardial infarction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 2
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Pericardial effusion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Pneumonitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 7
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 5
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Pneumothorax",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Pregnancy, puerperium and perinatal conditions - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 2
}
],
"organSystem": "Pregnancy, puerperium and perinatal conditions",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Psychosis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Respiratory failure",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Sepsis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 7
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Stroke",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Suicide attempt",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Supraventricular tachycardia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 3
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Syncope",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 2
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Thromboembolic event",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Typhlitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Vaginal dryness",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Reproductive system and breast disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Ventricular tachycardia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Leukemia secondary to oncology chemotherapy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Ejection fraction decreased",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 10
}
],
"organSystem": "Investigations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Acute coronary syndrome",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Upper gastrointestinal hemorrhage",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Enterocolitis infectious",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 2
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Lung infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Tricuspid valve disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Mitral valve disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Aortic valve disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Vascular access complication",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Small intestine infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Acute kidney injury",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
},
{
"term": "Left ventricular systolic dysfunction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 1615,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 1625,
"numAffected": 29
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE v4.0"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Percentage of Patients Alive and Free From Invasive Disease (IDFS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "89.2",
"groupId": "OG000"
},
{
"value": "89.8",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive and Disease-Free (DFS-DCIS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "89.1",
"groupId": "OG000"
},
{
"value": "89.6",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from a disease-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow-up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive and Free From Breast Cancer (BCFS)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "91.0",
"groupId": "OG000"
},
{
"value": "90.7",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from a breast cancer-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any cause.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive and Recurrence-Free (RFI)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "92.3",
"groupId": "OG000"
},
{
"value": "92.0",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from a recurrence-free interval event where events include invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes).",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow-up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive and Free From Distant Recurrence (DRFI)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1602",
"groupId": "OG000"
},
{
"value": "1598",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "93.6",
"groupId": "OG000"
},
{
"value": "92.7",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients free from a distant recurrence-free interval event where events include distant recurrence or death from breast cancer (censored for deaths from other causes), regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancer.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow-up"
},
{
"type": "SECONDARY",
"title": "Percentage of Patients Alive (Overall Survival)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1603",
"groupId": "OG000"
},
{
"value": "1602",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "96.3",
"groupId": "OG000"
},
{
"value": "94.8",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "5 years",
"description": "Percentage of patients alive.",
"unitOfMeasure": "percentage of patients alive",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with follow-up"
},
{
"type": "SECONDARY",
"title": "Toxicity Assessed by Adverse Events",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1615",
"groupId": "OG000"
},
{
"value": "1625",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "OG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "90.9",
"groupId": "OG000"
},
{
"value": "94.1",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose.",
"description": "Percentage of patients who ever experienced grade 2 or higher toxicites.",
"unitOfMeasure": "percentage of patients",
"reportingStatus": "POSTED",
"populationDescription": "Includes all at-risk patients with clinical follow-up."
},
{
"type": "SECONDARY",
"title": "Change in HER2 mRNA Level",
"timeFrame": "From baseline to 24 months",
"description": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy.",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants",
"anticipatedPostingDate": "2022-01"
},
{
"type": "SECONDARY",
"title": "Fcgamma Receptor Polymorphism",
"timeFrame": "From baseline to up to 24 months",
"description": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions.",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants",
"anticipatedPostingDate": "2022-01"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Arm I (Chemotherapy)",
"description": "<p>GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1.\nTreatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\nBeginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p>"
},
{
"id": "FG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "<p>GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA.\nPatients also receive trastuzumab IV over 30-90 minutes on day 1.\nCourses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB.\nPatients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses.\nTreatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.</p><p>Cyclophosphamide: Given IV</p><p>Docetaxel: Given IV</p><p>Doxorubicin: Given IV</p><p>Doxorubicin Hydrochloride: Given IV</p><p>Laboratory Biomarker Analysis: Correlative studies</p><p>Paclitaxel: Given IV</p><p>Quality-of-Life Assessment: Ancillary studies</p><p>Trastuzumab: Given IV</p>"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1630"
},
{
"groupId": "FG001",
"numSubjects": "1640"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1602"
},
{
"groupId": "FG001",
"numSubjects": "1598"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "28"
},
{
"groupId": "FG001",
"numSubjects": "42"
}
]
}
],
"dropWithdraws": [
{
"type": "Not at risk for recurrence.",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "No follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "26"
},
{
"groupId": "FG001",
"numSubjects": "37"
}
]
},
{
"type": "No clinical follow up.",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "4"
}
]
}
]
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1630",
"groupId": "BG000"
},
{
"value": "1640",
"groupId": "BG001"
},
{
"value": "3270",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Arm I (Chemotherapy)",
"description": "Arm I (chemotherapy)"
},
{
"id": "BG001",
"title": "Arm II (Chemotherapy, Trastuzumab)",
"description": "Arm II (chemotherapy, trastuzumab)"
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "52",
"spread": "10.4",
"groupId": "BG000"
},
{
"value": "52",
"spread": "10.4",
"groupId": "BG001"
},
{
"value": "52",
"spread": "10.4",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "1630",
"groupId": "BG000"
},
{
"value": "1640",
"groupId": "BG001"
},
{
"value": "3270",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "American Indian or Alaska Native",
"measurements": [
{
"value": "8",
"groupId": "BG000"
},
{
"value": "6",
"groupId": "BG001"
},
{
"value": "14",
"groupId": "BG002"
}
]
},
{
"title": "Asian",
"measurements": [
{
"value": "63",
"groupId": "BG000"
},
{
"value": "61",
"groupId": "BG001"
},
{
"value": "124",
"groupId": "BG002"
}
]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
"measurements": [
{
"value": "4",
"groupId": "BG000"
},
{
"value": "7",
"groupId": "BG001"
},
{
"value": "11",
"groupId": "BG002"
}
]
},
{
"title": "Black or African American",
"measurements": [
{
"value": "144",
"groupId": "BG000"
},
{
"value": "175",
"groupId": "BG001"
},
{
"value": "319",
"groupId": "BG002"
}
]
},
{
"title": "White",
"measurements": [
{
"value": "1370",
"groupId": "BG000"
},
{
"value": "1354",
"groupId": "BG001"
},
{
"value": "2724",
"groupId": "BG002"
}
]
},
{
"title": "More than one race",
"measurements": [
{
"value": "9",
"groupId": "BG000"
},
{
"value": "10",
"groupId": "BG001"
},
{
"value": "19",
"groupId": "BG002"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "32",
"groupId": "BG000"
},
{
"value": "27",
"groupId": "BG001"
},
{
"value": "59",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "Mutually exclusive and exhaustive",
"categories": [
{
"title": "Hispanic or Latino",
"measurements": [
{
"value": "102",
"groupId": "BG000"
},
{
"value": "106",
"groupId": "BG001"
},
{
"value": "208",
"groupId": "BG002"
}
]
},
{
"title": "Not Hispanic or Latino",
"measurements": [
{
"value": "1488",
"groupId": "BG000"
},
{
"value": "1513",
"groupId": "BG001"
},
{
"value": "3001",
"groupId": "BG002"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "40",
"groupId": "BG000"
},
{
"value": "21",
"groupId": "BG001"
},
{
"value": "61",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
}
]
}
}
}
]