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NCT03025035

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

Version 14 to 15 · Yuan Yuan

Patch inspector

Version 14 to 15

11 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_changeenrollment_count_changeenrollment_type_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_minor_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "later",
    "new_value": "2023-11-08",
    "old_value": "2023-11",
    "delta_days": 7,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_earlier_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2024-11-08",
    "old_value": "2025-11",
    "delta_days": 358,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 6,
    "old_value": 20,
    "pct_change": 0.7
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:41+00
Raw hash
0753a18dd749aa325bc493e101bb4483ea7c6491f5f49ee31c44c1626665e639
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 7
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
20
After
6
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 8
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ESTIMATED
After
ACTUAL
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2023-11
After
2023-11-08
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2025-11
After
2024-11-08
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 9
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
[
  {
    "name": "Parisa Mirzadehgan",
    "role": "CONTACT",
    "email": "Parisa.Mirzadehgan@cshs.org",
    "phone": "3109674387"
  }
]
remove /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 10
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 11
Before
[
  {
    "name": "Parisa Mirzadehgan, MPH",
    "role": "CONTACT",
    "email": "Parisa.Mirzadehgan@cshs.org",
    "phone": "310-967-4387"
  },
  {
    "name": "Monica Mita, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  },
  {
    "name": "Philomena McAndrew, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Dorothy Park, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Alain Mita, MD",
    "role": "SUB_INVESTIGATOR"
  },
  {
    "name": "Reva Basho, MD",
    "role": "SUB_INVESTIGATOR"
  }
]
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2022-05
After
2023-02
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2022-05-20
After
2023-02-01
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2022-05-26
After
2023-02-03
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 2
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2023-11-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2024-11-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-02-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-02-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 6
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ACTUAL"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/centralContacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/contacts"
  }
]