Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2022-09"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2022-03-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2022-03-31"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2022-09-23"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2022-10-21"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2022-01-31"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2022-09-23"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2022-10-21",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName",
"value": "Lisle Nabell"
},
{
"op": "replace",
"path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle",
"value": "Professor, Med-Hematology & Oncology"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
"value": "50 evaluable patients received the combination therapy of 2.5 gm daily oral Letrozole and Avastin 15 mg/kg IV every 3 weeks for 24 weeks."
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
"value": "25 evaluable patients received daily oral 2.5 mg letrozole as a single agent"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "The Percentage of Participants With Pathologic Complete Response"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Letrozole +Avastin"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Radiographic objective response to the therapy are reported.\nRadiographic response was assessed using RECIST criteria by ultrasound or breast MRI through the study and are reported as complete radiographic response below."
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/overallOfficials/0/name",
"value": "Lisle Nabell, M.D."
},
{
"op": "add",
"path": "/protocolSection/referencesModule",
"value": {
"availIpds": [
{
"url": "https://doi.org/10.1186/s13058-020-01258-x",
"type": "Clinical Study Report",
"comment": "Bevacizumab and Letrozole"
}
]
}
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "Lnabell@uabmc.edu",
"phone": "205 934-3061",
"title": "Lisle Nabell",
"organization": "UAB"
},
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": false
}
},
"adverseEventsModule": {
"timeFrame": "24 weeks of active treatment",
"eventGroups": [
{
"id": "EG000",
"title": "Letrozole + Avastin",
"description": "<p>Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks.</p><p>Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms.\nHypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.</p>",
"otherNumAtRisk": 50,
"deathsNumAtRisk": 50,
"otherNumAffected": 2,
"seriousNumAtRisk": 50,
"deathsNumAffected": 0,
"seriousNumAffected": 2
},
{
"id": "EG001",
"title": "Letrozole Alone",
"description": "Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks Adverse events typically associated with letrozole (hot flashes, arthralgias, fatigue, myalgias) occurred in similar frequencies in the two arms.\nHypertension, headache, and proteinuria were seen exclusively in the Let/Bev arm.",
"otherNumAtRisk": 25,
"deathsNumAtRisk": 25,
"otherNumAffected": 0,
"seriousNumAtRisk": 25,
"deathsNumAffected": 0,
"seriousNumAffected": 0
}
],
"otherEvents": [
{
"term": "Headache",
"notes": "Headache",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numEvents": 4,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 25,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "other"
}
],
"seriousEvents": [
{
"term": "Proteinuria",
"notes": "proteinuria 4%",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 50,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 25,
"numEvents": 0,
"numAffected": 0
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "other"
}
],
"frequencyThreshold": "2"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "The Percentage of Participants With Pathologic Complete Response",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "50",
"groupId": "OG000"
},
{
"value": "25",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Letrozole + Avastin",
"description": "Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks"
},
{
"id": "OG001",
"title": "Letrozole Alone",
"description": "Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "11",
"groupId": "OG000",
"lowerLimit": "3.7",
"upperLimit": "24.1"
},
{
"value": "0",
"groupId": "OG001",
"lowerLimit": "0",
"upperLimit": "14.2"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "24 weeks",
"description": "Pathological complete response is defined as the absence of residual invasive tumor in the breast or axillary lymph nodes or if only residual ductal carcinoma in-situ was seen on review of the surgical specimen.",
"unitOfMeasure": "percentage of participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Patients with postmenopausal hormone receptor positive breast cancer T2-4,N0-2 and M0 were randomized 2:1 to receive letrozole 2.5 mg PO daily and bevacizumab 15 mg/kg IV for 24 weeks or daily treatment with letrozole 2.5 mg PO alone (control arm).\nThe duration of each cycle was 3 weeks for a total of 24 weeks.\nThe pCR was defined as the absence of any residual invasive cancer in the resected breast specimen and lymph nodes.\nData below is representative of the raw data."
},
{
"type": "SECONDARY",
"title": "Letrozole +Avastin",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "50",
"groupId": "OG000"
},
{
"value": "25",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Letrozole + Avastin",
"description": "<p>50 evaluable patients received the combination therapy of 2.5 gm daily oral Letrozole and Avastin 15 mg/kg IV every 3 weeks for 24 weeks.</p><p>Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks</p>"
},
{
"id": "OG001",
"title": "Letrozole Alone",
"description": "<p>25 evaluable patients received daily oral 2.5 mg letrozole as a single agent</p><p>Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks</p>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "10",
"groupId": "OG000",
"lowerLimit": "3.4",
"upperLimit": "22"
},
{
"value": "4",
"groupId": "OG001",
"lowerLimit": "0",
"upperLimit": "20.4"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "24 weeks",
"description": "Radiographic objective response to the therapy are reported.\nRadiographic response was assessed using RECIST criteria by ultrasound or breast MRI through the study and are reported as complete radiographic response below.",
"unitOfMeasure": "participants",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "This was a single arm study to test the feasibility of Letrozole with Avastin in the neoadjuvant setting."
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Letrozole + Avastin",
"description": "Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks"
},
{
"id": "FG001",
"title": "Letrozole Alone",
"description": "Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "50"
},
{
"groupId": "FG001",
"numSubjects": "25"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "50"
},
{
"groupId": "FG001",
"numSubjects": "25"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
}
]
}
]
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "50",
"groupId": "BG000"
},
{
"value": "25",
"groupId": "BG001"
},
{
"value": "75",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Letrozole + Avastin",
"description": "Letrozole; Avastin: Letrozole 2.5 mg PO a day and Avastin 15 mg/kg IV every 3 weeks"
},
{
"id": "BG001",
"title": "Letrozole Alone",
"description": "Letrozole (Femara): Letrozole 2.5 mg PO a day for 24 weeks"
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Categorical",
"classes": [
{
"categories": [
{
"title": "<=18 years",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
},
{
"title": "Between 18 and 65 years",
"measurements": [
{
"value": "50",
"groupId": "BG000"
},
{
"value": "25",
"groupId": "BG001"
},
{
"value": "75",
"groupId": "BG002"
}
]
},
{
"title": ">=65 years",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "58",
"spread": "0.5",
"groupId": "BG000"
},
{
"value": "58",
"spread": "0.5",
"groupId": "BG001"
},
{
"value": "58",
"spread": "0.5",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "MEDIAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "50",
"groupId": "BG000"
},
{
"value": "25",
"groupId": "BG001"
},
{
"value": "75",
"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": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
},
{
"title": "Asian",
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
}
]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
},
{
"title": "Black or African American",
"measurements": [
{
"value": "7",
"groupId": "BG000"
},
{
"value": "3",
"groupId": "BG001"
},
{
"value": "10",
"groupId": "BG002"
}
]
},
{
"title": "White",
"measurements": [
{
"value": "40",
"groupId": "BG000"
},
{
"value": "20",
"groupId": "BG001"
},
{
"value": "60",
"groupId": "BG002"
}
]
},
{
"title": "More than one race",
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "1",
"groupId": "BG001"
},
{
"value": "1",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Region of Enrollment",
"classes": [
{
"title": "United States",
"categories": [
{
"measurements": [
{
"value": "50",
"groupId": "BG000"
},
{
"value": "25",
"groupId": "BG001"
},
{
"value": "75",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Study Participant",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "50",
"groupId": "BG000"
},
{
"value": "25",
"groupId": "BG001"
},
{
"value": "75",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
}
],
"populationDescription": "Postmenopausal women with newly diagnosed stage 2 or 3 estrogen and/or progesterone receptor-positive, HER2-negative breast cancer were randomly assigned (2:1) between letrozole 2.5 mg PO daily plus bevacizumab 15 mg/ kg IV every 3 weeks (Let/Bev) and letrozole 2.5 mg PO daily (Let) for 24 weeks prior to definitive surgery."
}
}
},
{
"op": "add",
"path": "/documentSection",
"value": {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2011-03-14",
"size": 556643,
"label": "Study Protocol and Statistical Analysis Plan",
"hasIcf": false,
"hasSap": true,
"filename": "Prot_SAP_000.pdf",
"typeAbbrev": "Prot_SAP",
"uploadDate": "2022-01-20T14:32",
"hasProtocol": true
}
]
}
}
}
]