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NCT03025035

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

Version 15 to 16 · Yuan Yuan

Patch inspector

Version 15 to 16

9 operations 4 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/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 20,
    "old_value": 6,
    "pct_change": 2.3333
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:41+00
Raw hash
e7e290f47c3a5de0e1a907d9141ef2717ebda674b44fd00e5c9cd2eb47864401
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 5
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
6
After
20
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 6
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ACTUAL
After
ESTIMATED
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 3 ops
add /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 7
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 8
After
[
  {
    "name": "Amy Oppenheim",
    "role": "CONTACT",
    "email": "Amy.Oppenheim@cshs.org",
    "phone": "310-423-3713"
  },
  {
    "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": "Maryliza El-Masry, MD",
    "role": "SUB_INVESTIGATOR"
  }
]
add /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 9
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
After
[
  {
    "name": "Amy Oppenheim",
    "role": "CONTACT",
    "email": "Amy.Oppenheim@cshs.org",
    "phone": "310-423-3713"
  }
]
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
2023-02
After
2023-06
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2023-02-01
After
2023-06-03
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2023-02-03
After
2023-06-06
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
ACTIVE_NOT_RECRUITING
After
RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-06-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-06-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 20
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ESTIMATED"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0/contacts",
    "value": [
      {
        "name": "Amy Oppenheim",
        "role": "CONTACT",
        "email": "Amy.Oppenheim@cshs.org",
        "phone": "310-423-3713"
      },
      {
        "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": "Maryliza El-Masry, MD",
        "role": "SUB_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/centralContacts",
    "value": [
      {
        "name": "Amy Oppenheim",
        "role": "CONTACT",
        "email": "Amy.Oppenheim@cshs.org",
        "phone": "310-423-3713"
      }
    ]
  }
]