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NCT03584009

A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

A Phase II, Multicenter, Randomized Study To Compare The Efficacy Of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

ClinicalTrials.gov
Sponsor
Hoffmann-La Roche
Status
Terminated
Versions
26
Adjacent patches
25
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

14 shown
Triage: Medium
2018-08-24
Timeline Shift
v2 to v3 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/11/status
/protocolSection/contactsLocationsModule/locations/7/status
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Low
2019-02-07
Timeline Actualized Earlier
v3 to v4 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
/protocolSection/contactsLocationsModule/locations/10/facility
Triage: High
2019-02-14
Eligibility Change
v4 to v5 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/15/status
/protocolSection/contactsLocationsModule/locations/19/status
/protocolSection/contactsLocationsModule/locations/33/status
Triage: Low
2019-03-15
Timeline Minor Adjustment
v5 to v6 Early Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Critical
2019-09-04
Primary Outcome Change
v8 to v9 Early Recruitment Inspect patch
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Low
2020-04-20
Timeline Minor Adjustment
v15 to v16 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
Triage: Medium
2020-07-03
Timeline Shift
v16 to v17 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
Triage: High
2020-08-03
Enrollment Change
v17 to v18 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
Triage: Low
2020-10-22
Milestone Realized
v18 to v19 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1/city
/protocolSection/contactsLocationsModule/locations/1/geoPoint/lat
/protocolSection/contactsLocationsModule/locations/1/geoPoint/lon
Triage: Critical
2020-11-09
Primary Outcome Change
v19 to v20 Late Recruitment Inspect patch Evidence Record
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/1/description
/protocolSection/armsInterventionsModule/interventions/0/description
Triage: Low
2021-06-10
Timeline Actualized Earlier
v21 to v22 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2021-07-20
Arm Intervention Change
v22 to v23 Post Recruitment Inspect patch Evidence Record
/annotationSection
/documentSection
/hasResults
Triage: Low
2021-08-31
Results Reconciliation
v23 to v24 Post Recruitment Inspect patch Evidence Record
/annotationSection
/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: High
2022-06-21
Arm Intervention Change
v24 to v25 Post Recruitment Inspect patch Evidence Record
/documentSection/largeDocumentModule/largeDocs/0/date
/documentSection/largeDocumentModule/largeDocs/0/filename
/documentSection/largeDocumentModule/largeDocs/0/size