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NCT05243641

Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

Version 12 to 13 · M.D. Anderson Cancer Center

Patch inspector

Version 12 to 13

8 operations 3 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
terminal_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": "2024-11-19",
    "old_value": "2028-12-31",
    "delta_days": 1503,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "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": "2024-11-19",
    "old_value": "2028-12-31",
    "delta_days": 1503,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:33+00
Raw hash
7419e41fd46f77523113e6fb2040a7592f6c469fc7bb109d7d8148e8d38fee40
Payload
Source URL
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 1
Matched rules
  • terminal_status_change Status changed to terminated, suspended, or withdrawn; whyStopped content determines whether critical review is warranted.
Before
ACTIVE_NOT_RECRUITING
After
TERMINATED
add /protocolSection/statusModule/whyStopped
Triage: High
Status Termination Operation 8
Matched rules
  • why_stopped_change Why-stopped changes explain discontinuation and need review.
After
Sponsor Withdrew Support
Timeline Start, primary completion, and completion date movement. Triage: Medium 4 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2028-12-31
After
2024-11-19
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 3
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 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2028-12-31
After
2024-11-19
replace /protocolSection/statusModule/completionDateStruct/type
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 6
Before
2024-11-18
After
2024-11-25
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 7
Before
2024-11-20
After
2024-11-27
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "TERMINATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2024-11-19"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2024-11-19"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2024-11-25"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2024-11-27"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/whyStopped",
    "value": "Sponsor Withdrew Support"
  }
]