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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 17 to 18 · M.D. Anderson Cancer Center

Patch inspector

Version 17 to 18

11 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

None recorded.

Value signals
[
  {
    "paths": [
      "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
      "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit"
    ],
    "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
26e78af52a7f18808f6235fb84f1d3d986ef3c881f4f73b8360a3c21bbee7bbf
Payload
Source URL
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 3 ops
add /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit
Triage: High
Secondary Outcome Change Operation 3
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
add /protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit
Triage: High
Secondary Outcome Change Operation 4
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
add /protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit
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.
After
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
Adverse events and safety Posted serious or other adverse event data. Triage: Uncategorized 2 ops
replace /resultsSection/adverseEventsModule/timeFrame
Triage: Uncategorized
Uncategorized Operation 9
Before
From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 3 years.
After
From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months.
remove /resultsSection/adverseEventsModule/reviewUnit
Triage: Uncategorized
Uncategorized Operation 10
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 3 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2025-04-08
After
2025-04-29
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 2
Before
2025-04-25
After
2025-05-01
replace /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
Triage: Uncategorized
Uncategorized Operation 11
Before
2025-04-24
After
2025-04-30
Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 3 ops
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit
Triage: Uncategorized
Uncategorized Operation 6
After
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit
Triage: Uncategorized
Uncategorized Operation 7
After
{
  "resetReasons": [
    "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  ]
}
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit
Triage: Uncategorized
Uncategorized Operation 8
After
{
  "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": "2025-04-29"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2025-05-01"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit",
    "value": {
      "resetReasons": [
        "The Time Frame appears inconsistent with information provided here or in other parts of the record."
      ]
    }
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/timeFrame",
    "value": "From the initiation of the first protocol-specific intervention to 2 years following the last dose of the drug, up to 27 months."
  },
  {
    "op": "remove",
    "path": "/resultsSection/adverseEventsModule/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
    "value": "2025-04-30"
  }
]