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NCT00099437

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy

ClinicalTrials.gov
Sponsor
AstraZeneca
Status
Active Not Recruiting
Versions
69
Adjacent patches
68
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

24 shown
Triage: High
2005-08-22
Design Change
v0 to v1 Early Recruitment Inspect patch
/protocolSection/designModule/designInfo/allocation
/protocolSection/designModule/designInfo/interventionModel
/protocolSection/designModule/designInfo/maskingInfo
Triage: High
2005-09-26
Eligibility Change
v1 to v2 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0
/protocolSection/contactsLocationsModule/locations/12/city
/protocolSection/contactsLocationsModule/locations/12/geoPoint/lat
Triage: Low
2007-10-29
Administrative Contact Change
v3 to v4 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
Triage: Critical
2007-12-14
Primary Outcome Change
v4 to v5 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels
/protocolSection/armsInterventionsModule/interventions/0/description
Triage: Medium
2008-04-29
Timeline Shift
v5 to v6 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/13/city
/protocolSection/contactsLocationsModule/locations/13/geoPoint/lat
/protocolSection/contactsLocationsModule/locations/13/geoPoint/lon
Triage: Medium
2009-04-21
Timeline Shift
v10 to v11 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2010-05-12
Arm Intervention Change
v15 to v16 Late Recruitment Inspect patch Evidence Record
/hasResults
/protocolSection/armsInterventionsModule/interventions/0/description
/protocolSection/contactsLocationsModule/locations/25/state
Triage: High
2010-11-26
Enrollment Change
v16 to v17 Post Recruitment Inspect patch
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
Triage: High
2014-08-29
Serious Adverse Event Addition
v22 to v23 Late Recruitment Inspect patch Evidence Record
/protocolSection/contactsLocationsModule/locations/0
/protocolSection/contactsLocationsModule/locations/11/state
/protocolSection/contactsLocationsModule/locations/12/city
Triage: Medium
2014-11-19
Timeline Significant Shift
v23 to v24 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2015-08-17
Timeline Major Slip
v27 to v28 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Medium
2016-11-07
Timeline Significant Shift
v32 to v33 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2017-05-25
Enrollment Change
v34 to v35 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/zip
/protocolSection/contactsLocationsModule/locations/1/zip
/protocolSection/contactsLocationsModule/locations/10/zip
Triage: Medium
2017-12-08
Timeline Significant Shift
v36 to v37 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/12
/protocolSection/contactsLocationsModule/locations/14
/protocolSection/statusModule/completionDateStruct/date
Triage: Medium
2019-02-27
Timeline Significant Shift
v41 to v42 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2019-12-03
Timeline Major Slip
v44 to v45 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/77/city
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Medium
2021-02-08
Timeline Shift
v48 to v49 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Medium
2021-03-12
Timeline Significant Shift
v49 to v50 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0
/protocolSection/contactsLocationsModule/locations/1
/protocolSection/contactsLocationsModule/locations/101
Triage: Medium
2021-11-25
Timeline Significant Shift
v52 to v53 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/zip
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Medium
2022-12-16
Timeline Significant Shift
v56 to v57 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Medium
2023-10-30
Timeline Significant Shift
v59 to v60 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2024-07-03
Timeline Major Slip
v61 to v62 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/101
/protocolSection/contactsLocationsModule/locations/32
/protocolSection/statusModule/completionDateStruct/date
Triage: Medium
2025-06-02
Timeline Significant Shift
v64 to v65 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/32
/protocolSection/contactsLocationsModule/locations/40
/protocolSection/statusModule/completionDateStruct/date
Triage: Medium
2026-02-26
Timeline Significant Shift
v66 to v67 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate