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

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2025-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-04-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2025-04-25"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "Adverse events (AEs) graded using CTCAE version 5.0: ≥ Grade 2 for non-hematological and ≥ Grade 3 for hematological AEs observed after the first protocol intervention for phase II patients."
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription",
    "value": "Patients treated at the MTD in phase II were intended to be evaluated.\nHowever, due to the study's termination during Phase Ib, no patients were analyzed for this objective."
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
    "value": "Adverse events (AEs) graded using CTCAE version 5.0: ≥ Grade 2 for non-hematological and ≥ Grade 3 for hematological AEs observed after the first protocol intervention for phase II patients."
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription",
    "value": "Patients treated at the MTD in phase II were intended to be evaluated.\nHowever, due to the study's termination during Phase Ib, no patients were analyzed for this objective."
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/0/value",
    "value": "14.3"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/0/categories/0/measurements/1/value",
    "value": "33.3"
  },
  {
    "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 3 years."
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAffected",
    "value": 6
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/eventGroups/3/deathsNumAffected",
    "value": 2
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/reviewUnit/resetReasons/0",
    "value": "The Time Frame appears inconsistent with information provided here or in other parts of the record."
  },
  {
    "op": "remove",
    "path": "/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit"
  },
  {
    "op": "replace",
    "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
    "value": "2025-04-24"
  },
  {
    "op": "replace",
    "path": "/reviewUnit/resetReasons/0",
    "value": "This record has new issues that must be addressed."
  }
]