Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2026-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "TERMINATED"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2024-07-16"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2024-07-16"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2026-01-02"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2026-01-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/whyStopped",
"value": "The study was prematurely halted primarily due to low patient accrual.\nDespite efforts to optimize recruitment, the enrollment rate remained insufficient to meet the predefined targets, and continuation was deemed unfeasible"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2025-09-05"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2026-01-02"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2026-01-06",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 5
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Disease-free Survival at 3years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes",
"value": [
{
"measure": "pCR Rate",
"timeFrame": "pCR assessment was done following surgery after neoadjuvant therapy with paclitaxel and trastuzumzb/pertuzumab prior to adjuvant therapy",
"description": "rate of pathological complete response (pCR) between the treatment groups by HR status"
},
{
"measure": "Patient Reported Outcomes (Global Health Status)",
"timeFrame": "The questionnaire was filled by the patients at screening and post adjuvant therapy.",
"description": "<p>The EORTC QLQ-C30 was used to assess Health-Related Quality of Life (QoL).\nThe measure consists of five functional scales (physical, role, cognitive, emotional, and social).\nFor this study, raw scores were used without any transformation.\nThe functional scales consist of multiple items (questions 1-28) scored on a 1-4 scale (1 = not at all, 4 = very much).\nHigher scores indicate worse functioning.\nTo assess the effect of standard therapy (surgery after neoadjuvant therapy) vs. investigational therapy (omission of surgery), the global health status is reported in each of these populations before and after treatment.</p><p>The Global Health Status (GHS) score is derived from two items (Q29 and Q30), each scored on a 1-7 scale (1 = very poor, 7 = excellent).</p><p>Scoring method: GHS = (Q29 + Q30) / 2 Raw score range: Minimum = (1 + 1) / 2 = 1; Maximum = (7 + 7) /2 = 7</p>"
}
]
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/centralContacts"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/0/status"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/state",
"value": "Barcelona"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "topascual@clinic.cat",
"phone": "932275400",
"title": "Dr. Tomas Pascual",
"organization": "Hospital Clínic de Barcelona"
},
"certainAgreement": {
"piSponsorEmployee": true
}
},
"adverseEventsModule": {
"timeFrame": "Study treatment duration - 1 year (neoadjuvant and adjuvant therapy)",
"eventGroups": [
{
"id": "EG000",
"title": "Treatment Arm (Treatment With Paclitaxel)",
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>",
"otherNumAtRisk": 5,
"deathsNumAtRisk": 5,
"otherNumAffected": 5,
"seriousNumAtRisk": 5,
"deathsNumAffected": 0,
"seriousNumAffected": 0
},
{
"id": "EG001",
"title": "Treatment Arm (Treatment With Trastuzumab)",
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>",
"otherNumAtRisk": 5,
"deathsNumAtRisk": 5,
"otherNumAffected": 5,
"seriousNumAtRisk": 5,
"deathsNumAffected": 0,
"seriousNumAffected": 0
},
{
"id": "EG002",
"title": "Treatment Arm (Treatment With Pertuzumab)",
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>",
"otherNumAtRisk": 5,
"deathsNumAtRisk": 5,
"otherNumAffected": 5,
"seriousNumAtRisk": 5,
"deathsNumAffected": 0,
"seriousNumAffected": 0
},
{
"id": "EG003",
"title": "Treatment Arm (Adjuvant Treatment With TDM1)",
"description": "TDM-1 administered on Day 1 of a 3-week cycle q3w at a doce of 3.6 mg/kg IV as adjuvant treatment in patients of the treatment population with non-complete response in the neoadjuvant setting",
"otherNumAtRisk": 3,
"deathsNumAtRisk": 3,
"otherNumAffected": 3,
"seriousNumAtRisk": 3,
"deathsNumAffected": 0,
"seriousNumAffected": 0
}
],
"otherEvents": [
{
"term": "alopecia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 7,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "asthenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 3,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "dysguesia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "anemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "arthralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 2,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 4,
"numAffected": 4
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "erythema face and hands",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "erythema arms and hands",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 3,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "feet erythema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "hands neurotoxicity",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "hiporexya",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "mucositis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "neurotoxicity in foot",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
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"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "occasional epistaxis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
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}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "onychodystrophy",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
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"numAffected": 0
},
{
"groupId": "EG002",
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"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
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"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "onycholysis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
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},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
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"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "plantar erythema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
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"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
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"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "erythematous reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Skin and subcutaneous tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "muscle pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 1,
"numAffected": 1
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "plaquetopenia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "decrease in hemoglobin",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "increase of total bilirubine",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Hepatobiliary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "alat increase",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 4,
"numAffected": 3
}
],
"organSystem": "Hepatobiliary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "asat increase",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Hepatobiliary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "epigastralgia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
},
{
"term": "increase of alkaline phosphatase",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 5,
"numEvents": 0,
"numAffected": 0
},
{
"groupId": "EG003",
"numAtRisk": 3,
"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Hepatobiliary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (5)"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Disease-free Survival at 3years",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Omision of Surgery (Complete Response)",
"description": "After completion of neoadjuvant therapy, if no invasive tumor cells and no in situ disease are identified in the stereotactic-guided VAB (complete response), patients will be eligible to omit loco-regional surgery"
}
],
"paramType": "MEDIAN",
"timeFrame": "3 years",
"description": "To estimate the loco-regional invasive disease-free survival (LR-IDFS) at 3-year of patients who achieve a complete response based on imaging and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery.",
"unitOfMeasure": "years",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "After completion of neoadjuvant therapy with paclitaxel and Trastuzumab/pertuzumab, out of 5 patients, only 3 patients showed complete response (assessed by MRI) and 2 patients (no stereo-guided VAB assessment) did not undergo surgery.\nHowever, the participants were lost to follow-up before 3-year assessments, so no evaluable 3-year survival data are available"
},
{
"type": "SECONDARY",
"title": "pCR Rate",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "1",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "HR Positive",
"description": "patients that are hormone receptor (HR) positive (assessment at baseline)"
},
{
"id": "OG001",
"title": "HR Negative",
"description": "Patients that are hormone receptor (HR) negative (assessed at baseline)"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"timeFrame": "pCR assessment was done following surgery after neoadjuvant therapy with paclitaxel and trastuzumzb/pertuzumab prior to adjuvant therapy",
"description": "rate of pathological complete response (pCR) between the treatment groups by HR status",
"unitOfMeasure": "Participants",
"reportingStatus": "POSTED",
"populationDescription": "While total number of HR positive patients and HR negative patients in the overall treatment group is 2 and 3 respectively, only 1 patient in the former and 2 patients in the later group were evaluated for pCR at surgery"
},
{
"type": "SECONDARY",
"title": "Patient Reported Outcomes (Global Health Status)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
},
{
"value": "2",
"groupId": "OG002"
},
{
"value": "2",
"groupId": "OG003"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Patients Who Underwent Surgery (Assessment at Screening)",
"description": "<p>Of the treatment population, those patients who underwent surgery post neoadjuvant therapy.</p><p>The assessment time period is at screening</p>"
},
{
"id": "OG001",
"title": "Patients Who Underwent Surgery (Assessment After Adjuvant Therapy)",
"description": "<p>Of the treatment population, those patients who underwent surgery post neoadjuvant therapy.</p><p>The assessment time period is after adjuvant therapy</p>"
},
{
"id": "OG002",
"title": "Patients With Omission of Surgery (Assessment at Screening)",
"description": "<p>Of the treatment population, those patients with omission of surgery post neoadjuvant therapy.</p><p>The assessment time period is at screening</p>"
},
{
"id": "OG003",
"title": "Patients With Omission of Surgery (Assessment After Adjuvant Therapy)",
"description": "<p>Of the treatment population, those patients who underwent surgery post neoadjuvant therapy.</p><p>The assessment time period is after adjuvant therapy</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "OG000",
"lowerLimit": "5",
"upperLimit": "6"
},
{
"value": "4",
"groupId": "OG001",
"lowerLimit": "3.5",
"upperLimit": "4.5"
},
{
"value": "5.25",
"groupId": "OG002",
"lowerLimit": "4.5",
"upperLimit": "6"
},
{
"value": "5",
"groupId": "OG003",
"lowerLimit": "4",
"upperLimit": "6"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "The questionnaire was filled by the patients at screening and post adjuvant therapy.",
"description": "<p>The EORTC QLQ-C30 was used to assess Health-Related Quality of Life (QoL).\nThe measure consists of five functional scales (physical, role, cognitive, emotional, and social).\nFor this study, raw scores were used without any transformation.\nThe functional scales consist of multiple items (questions 1-28) scored on a 1-4 scale (1 = not at all, 4 = very much).\nHigher scores indicate worse functioning.\nTo assess the effect of standard therapy (surgery after neoadjuvant therapy) vs. investigational therapy (omission of surgery), the global health status is reported in each of these populations before and after treatment.</p><p>The Global Health Status (GHS) score is derived from two items (Q29 and Q30), each scored on a 1-7 scale (1 = very poor, 7 = excellent).</p><p>Scoring method: GHS = (Q29 + Q30) / 2 Raw score range: Minimum = (1 + 1) / 2 = 1; Maximum = (7 + 7) /2 = 7</p>",
"unitOfMeasure": "score on a scale",
"dispersionType": "Full Range",
"reportingStatus": "POSTED",
"populationDescription": "Out of the treatment population, 3 patients underwent surgery post neoadjuvant therapy (standard therapy) and 2 patients did not undergo surgery (investigative therapy).\nAll the patients of both the groups completed the patient reported outcomes questionaire at screening. 1 patient from the patient group that underwent surgery did not complete the questionnaire after adjuvant therapy."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Treatment Arm",
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>"
}
],
"periods": [
{
"title": "Study treatment",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "5"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "5"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
}
]
}
]
},
{
"title": "Follow-up after 1 year",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "5"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "4"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1"
}
]
}
],
"dropWithdraws": [
{
"type": "Lost to Follow-up",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
]
}
]
},
{
"title": "Follow up at 3 yrs",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "4"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "4"
}
]
}
]
}
],
"recruitmentDetails": "Overall, 20 patients were screened for the study in a single study centre (clinical setting) over the duration of 18 months.\nA total of 5 patients were finally selected for the study treatment after meeting all the inclusion criteria and signing the ICF",
"preAssignmentDetails": "<p>Out of 20 patients screened, 13 patients did not fulfill the study criteria (PAM50 subtype other than HER2-Enriched, ERBB2 high, liver metastasis, multicentric tumor).</p><p>Finally only 5 patients that fulfilled all eligibility criteria and signed the ICF were included</p>"
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "5",
"groupId": "BG000"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Treatment Arm",
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>"
}
],
"measures": [
{
"title": "Age, Customized",
"classes": [
{
"title": ">= 40 yrs",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "5",
"groupId": "BG000"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race/Ethnicity, Customized",
"classes": [
{
"title": "Caucasian",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "Spain",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
},
{
"title": "Menopausal Status",
"classes": [
{
"title": "Postmenopausal (min 12 mnths without menses before neoadyuvance treatment)",
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "BG000"
}
]
}
]
},
{
"title": "premenopausal",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
},
{
"title": "ECOG baseline",
"classes": [
{
"title": "Grade 0",
"categories": [
{
"measurements": [
{
"value": "4",
"groupId": "BG000"
}
]
}
]
},
{
"title": "Grade 1",
"categories": [
{
"measurements": [
{
"value": "1",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "NUMBER",
"description": "Scale: Grades 0-4 Grade 0 - Fully active able to carry on all pre-disease performance without restriction; Grade 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g.\nlight house work office work; Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours Grade 3 - Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade 4 - Completely disabled; cannot carry on any selfcare; totally confined to bed or chair",
"unitOfMeasure": "participants"
},
{
"title": "Previous cancer history",
"classes": [
{
"title": "Yes",
"categories": [
{
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
}
]
},
{
"title": "No",
"categories": [
{
"measurements": [
{
"value": "5",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "NUMBER",
"unitOfMeasure": "participants"
}
],
"populationDescription": "The baseline analysis population is the same as the treatment population"
}
}
},
{
"op": "add",
"path": "/documentSection",
"value": {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2019-10-17",
"size": 4292401,
"label": "Study Protocol and Statistical Analysis Plan",
"hasIcf": false,
"hasSap": true,
"filename": "Prot_SAP_000.pdf",
"typeAbbrev": "Prot_SAP",
"uploadDate": "2025-09-03T04:05",
"hasProtocol": true
}
]
}
}
}
]