Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2025-05"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2025-05-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2025-05-23"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Defined as complete or partial response or stable disease per RECIST 1.1 criteria with assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter.\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither shrinking sufficiently to be considered a partial response (PR) (at least 30% decrease in tumor burden), nor growing significantly enough to be considered progressive disease (PD) (more than 20% increase in tumor burden); Overall Response (OR) = CR + PR + SD"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "until all patients off study"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/0/description",
"value": "<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 and/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>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
"value": "Defined as complete or partial response or stable disease per RECIST 1.1 criteria with assessment every 9 weeks during the first year and while on the study drug, and every 12 weeks thereafter.\nPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither shrinking sufficiently to be considered a partial response (PR) (at least 30% decrease in tumor burden), nor growing significantly enough to be considered progressive disease (PD) (more than 20% increase in tumor burden); Overall Response (OR) = CR + PR + SD"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
"value": "until all patients off study"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
"value": 6
},
{
"op": "remove",
"path": "/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit"
},
{
"op": "replace",
"path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
"value": "2025-05-22"
},
{
"op": "add",
"path": "/reviewUnit",
"value": {
"resetReasons": [
"This record has new issues that must be addressed."
]
}
}
]