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NCT03734029

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

ClinicalTrials.gov
Sponsor
Daiichi Sankyo
Status
Active Not Recruiting
Versions
33
Adjacent patches
32
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

13 shown
Triage: Critical
2018-12-13
Primary Outcome Change
v0 to v1 Pre Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/interventions/0/description
/protocolSection/descriptionModule/briefSummary
Triage: Low
2018-12-19
Administrative Contact Change
v1 to v2 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations
/protocolSection/ipdSharingStatementModule/description
Triage: Low
2019-01-07
Timeline Minor Adjustment
v2 to v3 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/2
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Low
2019-02-15
Timeline Minor Adjustment
v4 to v5 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0
/protocolSection/contactsLocationsModule/locations/2
/protocolSection/contactsLocationsModule/locations/3
Triage: Critical
2019-07-19
Primary Outcome Change
v9 to v10 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/0/label
/protocolSection/armsInterventionsModule/armGroups/1/description
Triage: Low
2020-02-03
Administrative Contact Change
v15 to v16 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/name
/protocolSection/contactsLocationsModule/centralContacts/1
/protocolSection/contactsLocationsModule/locations/11
Triage: High
2021-01-07
Design Change
v24 to v25 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: Medium
2022-12-14
Timeline Shift
v26 to v27 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2023-02-15
Adverse Event Group Change
v28 to v29 Late Recruitment Inspect patch Evidence Record
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/1
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/2
Triage: High
2023-05-25
Adverse Event Group Change
v29 to v30 Late Recruitment Inspect patch Evidence Record
/annotationSection
/protocolSection/outcomesModule/otherOutcomes
/protocolSection/outcomesModule/secondaryOutcomes/1
Triage: High
2024-04-09
Timeline Major Slip
v30 to v31 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Medium
2025-09-16
Timeline Significant Shift
v31 to v32 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1/zip
/protocolSection/contactsLocationsModule/locations/24/zip
/protocolSection/contactsLocationsModule/locations/3/zip