Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/identificationModule/briefTitle",
"value": "Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer"
},
{
"op": "replace",
"path": "/protocolSection/identificationModule/officialTitle",
"value": "Open Label, Phase II Pilot Study of Immune Checkpoint Inhibition With Pembrolizumab in Combination With PARP Inhibition With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancers"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2025-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2025-04-29"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2025-05-09"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2025-04-29"
},
{
"op": "remove",
"path": "/protocolSection/oversightModule/isUsExport"
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 14
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Overall Response Rate (ORR) Per RECIST1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Progression Free Survival (PFS), Per RECIST 1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Overall Survival (OS)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Clinical Benefit Rate (CBR = CR+PR+SD) Per RECIST 1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Duration of Response (DOR) for Complete Response (CR) and Partial Response (PR) Per RECIST 1.1"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "yuan.yuan@cshs.org",
"phone": "3108888680",
"title": "Yuan Yuan, MD, PhD",
"organization": "Cedars-Sinai Medical Center"
},
"certainAgreement": {
"piSponsorEmployee": true
}
},
"adverseEventsModule": {
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"eventGroups": [
{
"id": "EG000",
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"deathsNumAtRisk": 11,
"otherNumAffected": 11,
"seriousNumAtRisk": 11,
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"seriousNumAffected": 0
}
],
"otherEvents": [
{
"term": "Anemia Hemoglobin",
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{
"groupId": "EG000",
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"numAffected": 6
}
],
"organSystem": "Blood and lymphatic system disorders",
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},
{
"term": "Anorexia",
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{
"groupId": "EG000",
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"numAffected": 2
}
],
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},
{
"term": "Anorexia",
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{
"groupId": "EG000",
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}
],
"organSystem": "Gastrointestinal disorders",
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},
{
"term": "Anxiety",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
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},
{
"term": "Back Pain",
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{
"groupId": "EG000",
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"numAffected": 3
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Bloating",
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{
"groupId": "EG000",
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"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Blood Bilirubin Increased",
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{
"groupId": "EG000",
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"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Concentration Impairment",
"stats": [
{
"groupId": "EG000",
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"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
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"numEvents": 3,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 11,
"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Creatinine increased",
"stats": [
{
"groupId": "EG000",
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"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Renal and urinary disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Diarrhea",
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{
"groupId": "EG000",
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"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
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},
{
"term": "Dizziness",
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{
"groupId": "EG000",
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"numAffected": 2
}
],
"organSystem": "Nervous system disorders",
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},
{
"term": "Dysgeusia",
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{
"groupId": "EG000",
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"numAffected": 2
}
],
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},
{
"term": "Dysgeusia",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Edema Limbs",
"stats": [
{
"groupId": "EG000",
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"numAffected": 2
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Eye disorders - Other",
"stats": [
{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Eye disorders",
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},
{
"term": "Eye pain",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Eye disorders",
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},
{
"term": "Eyelid Function Disorder",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Eye disorders",
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},
{
"term": "Fall",
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{
"groupId": "EG000",
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"numAffected": 2
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Fatigue",
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{
"groupId": "EG000",
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"numAffected": 4
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Flank Pain",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Gastroesophagael Reflux",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Headache",
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{
"groupId": "EG000",
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}
],
"organSystem": "Nervous system disorders",
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},
{
"term": "Hypercalcemia",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Metabolism and nutrition disorders",
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},
{
"term": "Hyperthyroidism",
"stats": [
{
"groupId": "EG000",
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"numEvents": 2,
"numAffected": 2
}
],
"organSystem": "Endocrine disorders",
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},
{
"term": "Insomnia",
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{
"groupId": "EG000",
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"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Psychiatric disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Joint Range of Motion Decreased",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
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},
{
"term": "Malaise",
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{
"groupId": "EG000",
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}
],
"organSystem": "General disorders",
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},
{
"term": "Mucositis Oral",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
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},
{
"term": "Myalgia",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
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},
{
"term": "Nausea",
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{
"groupId": "EG000",
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}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Non-Cardiac Chest Pain",
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{
"groupId": "EG000",
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"numEvents": 2,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Oral Pain",
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{
"groupId": "EG000",
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"numEvents": 1,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT"
},
{
"term": "Other- Pain at Biopsy Site",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "General disorders",
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},
{
"term": "Other- Tinnitus",
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{
"groupId": "EG000",
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}
],
"organSystem": "Ear and labyrinth disorders",
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},
{
"term": "Other- Muscle Cramps",
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{
"groupId": "EG000",
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],
"organSystem": "Musculoskeletal and connective tissue disorders",
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},
{
"term": "Pain",
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{
"groupId": "EG000",
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}
],
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},
{
"term": "Pain in Extremity",
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{
"groupId": "EG000",
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}
],
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},
{
"term": "Palpitations",
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{
"groupId": "EG000",
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],
"organSystem": "Cardiac disorders",
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},
{
"term": "Paresthesia",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Cardiac disorders",
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},
{
"term": "Peripheral Sensory Neuropathy",
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{
"groupId": "EG000",
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"numAffected": 1
}
],
"organSystem": "Nervous system disorders",
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},
{
"term": "Postnasal Drip",
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{
"groupId": "EG000",
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}
],
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},
{
"term": "Stomach Pain",
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{
"groupId": "EG000",
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}
],
"organSystem": "Gastrointestinal disorders",
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},
{
"term": "Thromboembolic Event",
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{
"groupId": "EG000",
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}
],
"organSystem": "Vascular disorders",
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},
{
"term": "Vomiting",
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{
"groupId": "EG000",
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"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
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},
{
"term": "White blood cell decreased",
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{
"groupId": "EG000",
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}
],
"organSystem": "Injury, poisoning and procedural complications",
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},
{
"term": "Other- Injection Site Pain (Intermittent)",
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{
"groupId": "EG000",
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],
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}
],
"frequencyThreshold": "0",
"allCauseMortalityReviewUnit": {
"resetReasons": [
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]
}
},
"outcomeMeasuresModule": {
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{
"type": "PRIMARY",
"title": "Overall Response Rate (ORR) Per RECIST1.1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "11",
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}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Pembrolizumab + Olaparib",
"description": "<p>This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.</p><p>Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle</p><p>Olaparib: Olaparib administered orally twice a day</p>"
}
],
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{
"categories": [
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"measurements": [
{
"value": "7",
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}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
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"unitOfMeasure": "Participants",
"reportingStatus": "POSTED"
},
{
"type": "SECONDARY",
"title": "Progression Free Survival (PFS), Per RECIST 1.1",
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"description": "As measured by RECIST 1.1, in patients progressing after 1st line therapy",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants"
},
{
"type": "SECONDARY",
"title": "Overall Survival (OS)",
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"description": "Calculated in months from the start of treatment to the date of death from any cause",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants"
},
{
"type": "SECONDARY",
"title": "Clinical Benefit Rate (CBR = CR+PR+SD) Per RECIST 1.1",
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"description": "As measured by RECIST 1.1, in patients progressing after 1st line therapy",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants"
},
{
"type": "SECONDARY",
"title": "Duration of Response (DOR) for Complete Response (CR) and Partial Response (PR) Per RECIST 1.1",
"timeFrame": "Up to 2 years",
"description": "As measured by RECIST 1.1, in patients progressing after 1st line therapy",
"reportingStatus": "NOT_POSTED",
"denomUnitsSelected": "Participants"
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"title": "Pembrolizumab + Olaparib",
"description": "<p>This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.</p><p>Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle</p><p>Olaparib: Olaparib administered orally twice a day</p>"
}
],
"periods": [
{
"title": "Overall Study",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
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}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
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}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
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}
]
}
],
"dropWithdraws": [
{
"type": "Death",
"reasons": [
{
"groupId": "FG000",
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}
]
},
{
"type": "Disease progression and was taken off study. Only received pembrolizumab & is not evaluable.",
"reasons": [
{
"groupId": "FG000",
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}
]
}
]
}
]
},
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{
"units": "Participants",
"counts": [
{
"value": "11",
"groupId": "BG000"
}
]
}
],
"groups": [
{
"id": "BG000",
"title": "Pembrolizumab + Olaparib",
"description": "<p>This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.</p><p>Pembrolizumab: Pembrolizumab IV solution administered on Day 1 of each 3-week cycle</p><p>Olaparib: Olaparib administered orally twice a day</p>"
}
],
"measures": [
{
"title": "Age, Categorical",
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{
"categories": [
{
"title": "<=18 years",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Between 18 and 65 years",
"measurements": [
{
"value": "7",
"groupId": "BG000"
}
]
},
{
"title": ">=65 years",
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{
"value": "4",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Age, Continuous",
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{
"categories": [
{
"measurements": [
{
"value": "54.45455",
"spread": "13.09476",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "MEAN",
"unitOfMeasure": "years",
"dispersionType": "STANDARD_DEVIATION"
},
{
"title": "Sex: Female, Male",
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{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "11",
"groupId": "BG000"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Ethnicity (NIH/OMB)",
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{
"categories": [
{
"title": "Hispanic or Latino",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Not Hispanic or Latino",
"measurements": [
{
"value": "11",
"groupId": "BG000"
}
]
},
{
"title": "Unknown or Not Reported",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Race (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "American Indian or Alaska Native",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Asian",
"measurements": [
{
"value": "1",
"groupId": "BG000"
}
]
},
{
"title": "Native Hawaiian or Other Pacific Islander",
"measurements": [
{
"value": "0",
"groupId": "BG000"
}
]
},
{
"title": "Black or African American",
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