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NCT03025035

Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer

Version 18 to 19 · Yuan Yuan

Patch inspector

Version 18 to 19

12 operations 5 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
contact_admin_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2024-10-08",
    "old_value": "2026-08-08",
    "delta_days": 669,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:42+00
Raw hash
6b035df798d51b22ba5fb4c511538697322b55c3fe2f00340feafd3a07ee97d1
Payload
Source URL
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2026-08-08
After
2024-10-08
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 3 ops
remove /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 10
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
[
  {
    "name": "Amy Oppenheim",
    "role": "CONTACT",
    "email": "Amy.Oppenheim@cshs.org",
    "phone": "310-423-3713"
  }
]
remove /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 11
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 12
Before
[
  {
    "name": "Amy Oppenheim",
    "role": "CONTACT",
    "email": "Amy.Oppenheim@cshs.org",
    "phone": "310-423-3713"
  },
  {
    "name": "Philomena McAndrew, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Dorothy Park, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Maryliza El-Masry, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Yuan Yuan, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2024-08
After
2024-12
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 7
Before
2024-08-19
After
2024-12-06
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 8
Before
2024-08-21
After
2024-12-11
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 3 ops
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer
After
Pembrolizumab in Combination with Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer
replace /protocolSection/identificationModule/officialTitle
Triage: Uncategorized
Uncategorized Operation 2
Before
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
After
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
add /protocolSection/oversightModule/isUsExport
Triage: Uncategorized
Uncategorized Operation 9
After
false
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: Uncategorized 1 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 4
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
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": "2024-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2024-10-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2024-12-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2024-12-11"
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isUsExport",
    "value": false
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/centralContacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/contacts"
  }
]