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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

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

ClinicalTrials.gov
Sponsor
M.D. Anderson Cancer Center
Status
Terminated
Versions
21
Adjacent patches
20
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. New Evidence Record packages are generated for deterministic event-class membership, not by triage rank alone.

Material event timeline

12 shown
Triage: Low
2022-08-22
Timeline Minor Adjustment
v0 to v1 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/identificationModule/secondaryIdInfos
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2022-10-26
Arm Intervention Change
v2 to v3 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/description
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/identificationModule/briefTitle
Triage: High
2024-05-13
Eligibility Change
v8 to v9 Early Recruitment Inspect patch
/protocolSection/descriptionModule/detailedDescription
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
2024-05-15
Eligibility Change
v9 to v10 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2024-11-18
Enrollment Change
v11 to v12 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: High
2024-11-25
Status Termination
v12 to v13 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Low
2025-01-28
Results Reconciliation
v13 to v14 Post Recruitment Inspect patch Evidence Record
/annotationSection
/documentSection/largeDocumentModule/largeDocs/0
/hasResults
Triage: High
2025-02-24
Serious Adverse Event Addition
v14 to v15 Post Recruitment Inspect patch
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/statusVerifiedDate
Triage: Low
2025-03-24
Results Reconciliation
v15 to v16 Post Recruitment Inspect patch Evidence Record
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/protocolSection/outcomesModule/primaryOutcomes/1/description
/protocolSection/outcomesModule/primaryOutcomes/1/measure
Triage: High
2025-04-08
Adverse Event Group Change
v16 to v17 Post Recruitment Inspect patch Evidence Record
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/protocolSection/outcomesModule/secondaryOutcomes/0/description
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Low
2025-04-29
Results Reconciliation
v17 to v18 Post Recruitment Inspect patch Evidence Record
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit
Triage: Low
2025-04-30
Results Reconciliation
v18 to v19 Post Recruitment Inspect patch Evidence Record
/annotationSection
/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame