Back to feed

NCT02340221

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

ClinicalTrials.gov
Sponsor
Hoffmann-La Roche
Status
Terminated
Versions
64
Adjacent patches
63
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

19 shown
Triage: Low
2015-02-05
Timeline Minor Adjustment
v1 to v2 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/city
/protocolSection/contactsLocationsModule/locations/0/geoPoint
/protocolSection/contactsLocationsModule/locations/0/state
Triage: High
2015-03-16
Secondary Outcome Change
v6 to v7 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/75
/protocolSection/contactsLocationsModule/locations/78
/protocolSection/contactsLocationsModule/locations/79
Triage: High
2015-04-02
Secondary Outcome Change
v8 to v9 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/10
/protocolSection/contactsLocationsModule/locations/13
/protocolSection/contactsLocationsModule/locations/15
Triage: High
2015-05-11
Secondary Outcome Change
v10 to v11 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/10
/protocolSection/contactsLocationsModule/locations/100
Triage: Low
2015-11-02
Timeline Minor Adjustment
v19 to v20 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
/protocolSection/contactsLocationsModule/locations/10/status
Triage: Medium
2015-11-19
Timeline Shift
v20 to v21 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
/protocolSection/contactsLocationsModule/locations/10/status
Triage: Low
2016-03-01
Administrative Contact Change
v24 to v25 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/phone
/protocolSection/contactsLocationsModule/locations/100/status
/protocolSection/contactsLocationsModule/locations/102/status
Triage: Medium
2016-07-01
Timeline Shift
v28 to v29 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/103/status
/protocolSection/contactsLocationsModule/locations/113/status
/protocolSection/contactsLocationsModule/locations/114/status
Triage: Critical
2017-05-15
Primary Outcome Change
v34 to v35 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
Triage: Low
2017-06-14
Timeline Minor Adjustment
v35 to v36 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/103/status
/protocolSection/contactsLocationsModule/locations/119/status
/protocolSection/contactsLocationsModule/locations/122/status
Triage: Low
2017-07-10
Timeline Actual Date Correction
v36 to v37 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/100/status
/protocolSection/contactsLocationsModule/locations/105/status
/protocolSection/contactsLocationsModule/locations/117/status
Triage: Medium
2017-09-21
Timeline Major Slip
v39 to v40 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/102/status
/protocolSection/contactsLocationsModule/locations/118/status
/protocolSection/contactsLocationsModule/locations/12/status
Triage: High
2017-11-30
Enrollment Change
v40 to v41 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/city
/protocolSection/contactsLocationsModule/locations/0/facility
Triage: High
2018-04-11
Timeline Major Slip
v43 to v44 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/36/zip
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2019-01-22
Arm Intervention Change
v45 to v46 Late Recruitment Inspect patch Evidence Record
/annotationSection
/documentSection
/hasResults
Triage: Low
2021-06-15
Timeline Minor Adjustment
v55 to v56 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/126
/protocolSection/contactsLocationsModule/locations/130
/protocolSection/contactsLocationsModule/locations/73/zip
Triage: Low
2021-07-12
Timeline Minor Adjustment
v56 to v57 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/122/facility
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
Triage: Low
2022-01-19
Timeline Actual Date Correction
v61 to v62 Post Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2022-07-11
Status Termination
v62 to v63 Post Recruitment Inspect patch Evidence Record
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/1
/protocolSection/outcomesModule/secondaryOutcomes/0/measure