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NCT04756765

Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer

Version 9 to 10 · Stanford University

Patch inspector

Version 9 to 10

15 operations 6 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_changeterminal_status_changewhy_stopped_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": "2024-12-18",
    "old_value": "2025-03",
    "delta_days": 73,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2024-12-18",
    "old_value": "2025-03",
    "delta_days": 73,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_zeroed",
    "category": "enrollment_change",
    "severity": "critical",
    "new_value": 0,
    "old_value": 30,
    "pct_change": 1
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:23+00
Raw hash
8b807468de0e253ef83f5fda8c590fef89b460e3814bea3f2c6781d002c48ed9
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 11
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
30
After
0
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 12
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ESTIMATED
After
ACTUAL
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: High 2 ops
replace /protocolSection/statusModule/overallStatus
Triage: High
Status Termination Operation 3
Matched rules
  • terminal_status_change Status changed to terminated, suspended, or withdrawn; whyStopped content determines whether critical review is warranted.
Before
RECRUITING
After
WITHDRAWN
add /protocolSection/statusModule/whyStopped
Triage: High
Status Termination Operation 10
Matched rules
  • why_stopped_change Why-stopped changes explain discontinuation and need review.
After
Due to changes in the treatment landscape, the study faced significant recruitment challenges.
As no patients were enrolled, the sponsor requested study closure
Timeline Start, primary completion, and completion date movement. Triage: Medium 4 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2025-03
After
2024-12-18
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2025-03
After
2024-12-18
replace /protocolSection/statusModule/completionDateStruct/type
Triage: Medium
Timeline Shift Operation 7
Matched rules
  • completion_timeline_change 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 13
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
[
  {
    "name": "Nuzhat Shaikh",
    "role": "CONTACT",
    "email": "njshaikh@stanford.edu",
    "phone": "650-723-0659"
  }
]
remove /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 14
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 15
Before
[
  {
    "name": "Nuzhat Shaikh",
    "role": "CONTACT",
    "email": "njshaikh@stanford.edu",
    "phone": "650-723-0659"
  },
  {
    "name": "Melinda Telli, 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 2
Before
2024-09
After
2025-08
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 8
Before
2024-09-14
After
2025-08-13
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 9
Before
2024-09-19
After
2025-08-17
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops
add /protocolSection/identificationModule/secondaryIdInfos/1
Triage: Uncategorized
Uncategorized Operation 1
After
{
  "id": "NCI-2023-01961",
  "type": "REGISTRY",
  "domain": "National Cancer Institute: Clinical Trials Reporting Program"
}
Raw JSON Patch 
[
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/1",
    "value": {
      "id": "NCI-2023-01961",
      "type": "REGISTRY",
      "domain": "National Cancer Institute: Clinical Trials Reporting Program"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2025-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "WITHDRAWN"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2024-12-18"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2024-12-18"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-08-13"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2025-08-17"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/whyStopped",
    "value": "Due to changes in the treatment landscape, the study faced significant recruitment challenges.\nAs no patients were enrolled, the sponsor requested study closure"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 0
  },
  {
    "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"
  }
]