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

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                        "value": "10",
                        "groupId": "BG000"
                      },
                      {
                        "value": "10",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Male",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Ethnicity (NIH/OMB)",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "2",
                        "groupId": "BG000"
                      },
                      {
                        "value": "2",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Not Hispanic or Latino",
                    "measurements": [
                      {
                        "value": "8",
                        "groupId": "BG000"
                      },
                      {
                        "value": "8",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Race (NIH/OMB)",
            "classes": [
              {
                "categories": [
                  {
                    "title": "American Indian or Alaska Native",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Asian",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Native Hawaiian or Other Pacific Islander",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Black or African American",
                    "measurements": [
                      {
                        "value": "4",
                        "groupId": "BG000"
                      },
                      {
                        "value": "4",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "White",
                    "measurements": [
                      {
                        "value": "5",
                        "groupId": "BG000"
                      },
                      {
                        "value": "5",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "More than one race",
                    "measurements": [
                      {
                        "value": "1",
                        "groupId": "BG000"
                      },
                      {
                        "value": "1",
                        "groupId": "BG002"
                      }
                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "BG000"
                      },
                      {
                        "value": "0",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Region of Enrollment",
            "classes": [
              {
                "title": "United States",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "10",
                        "groupId": "BG000"
                      },
                      {
                        "value": "10",
                        "groupId": "BG002"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "unitOfMeasure": "participants"
          }
        ],
        "reviewUnit": {
          "resetReasons": [
            "The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided."
          ]
        },
        "populationDescription": "Baseline analysis population included all participants treated.\nThe study was terminated during phase Ib, resulting in no patient enrollment for phase II."
      }
    }
  },
  {
    "op": "add",
    "path": "/annotationSection",
    "value": {
      "annotationModule": {
        "unpostedAnnotation": {
          "unpostedEvents": [
            {
              "date": "2025-02-19",
              "type": "RESET"
            }
          ],
          "unpostedResponsibleParty": "M.D. Anderson Cancer Center"
        }
      }
    }
  }
]