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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 18 to 19 · M.D. Anderson Cancer Center

Patch inspector

Version 18 to 19

18 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

None recorded.

Value signals
[
  {
    "paths": [
      "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
      "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:35+00
Raw hash
a006da8e77fd8fc9b449d74ea87549ac520718811cc663c736f743f25bed1f0b
Payload
Source URL
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 6 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 5
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 3 years
After
Up to 27 months
remove /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit
Triage: High
Secondary Outcome Change Operation 6
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 7
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 3 years
After
Up to 27 months
remove /protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit
Triage: High
Secondary Outcome Change Operation 8
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
replace /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
Triage: High
Secondary Outcome Change Operation 9
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 3 years
After
Up to 27 months
remove /protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit
Triage: High
Secondary Outcome Change Operation 10
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 6 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2025-04-29
After
2025-04-30
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 2
Before
2025-05-01
After
2025-05-15
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 3
After
2025-04-30
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 4
After
{
  "date": "2025-05-15",
  "type": "ACTUAL"
}
remove /annotationSection
Triage: Uncategorized
Uncategorized Operation 17
Before
{
  "annotationModule": {
    "unpostedAnnotation": {
      "unpostedEvents": [
        {
          "date": "2025-04-30",
          "type": "RESET"
        }
      ],
      "unpostedResponsibleParty": "M.D. Anderson Cancer Center"
    }
  }
}
remove /reviewUnit
Triage: Uncategorized
Uncategorized Operation 18
Before
{
  "resetReasons": [
    "This record has new issues that must be addressed."
  ]
}
Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 6 ops
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame
Triage: Uncategorized
Uncategorized Operation 11
Before
Up to 3 years
After
Up to 27 months
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit
Triage: Uncategorized
Uncategorized Operation 12
Before
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame
Triage: Uncategorized
Uncategorized Operation 13
Before
Up to 3 years
After
Up to 27 months
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit
Triage: Uncategorized
Uncategorized Operation 14
Before
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame
Triage: Uncategorized
Uncategorized Operation 15
Before
Up to 3 years
After
Up to 27 months
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit
Triage: Uncategorized
Uncategorized Operation 16
Before
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-04-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2025-05-15"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2025-04-30"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2025-05-15",
      "type": "ACTUAL"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "Up to 27 months"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "Up to 27 months"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "value": "Up to 27 months"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
    "value": "Up to 27 months"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
    "value": "Up to 27 months"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
    "value": "Up to 27 months"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit"
  },
  {
    "op": "remove",
    "path": "/annotationSection"
  },
  {
    "op": "remove",
    "path": "/reviewUnit"
  }
]