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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.

Study acronym: CONFIRM
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 70 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    2 amendments

    2 re-verifications since 2026-06-10, no change to tracked fields

    v69-v70

  2. Minor

    Completion date: Dec 31, 2025 to Dec 31, 2026

    Study Statusv68

  3. Minor

    Site details revised at 1 of 106 sites

    Study Status, Contacts/Locationsv67

  4. Minor

    Study sites: 104 to 106

    Completion date: Mar 31, 2025 to Dec 31, 2025

    Study Status, Contacts/Locationsv66

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v65

Show 44 earlier versions

  1. Minor

    Study sites: 103 to 104

    Study Status, Contacts/Locationsv64

  2. Minor

    Completion date: Mar 29, 2024 to Mar 31, 2025

    Site details revised at 70 of 103 sites

    Study Status, Contacts/Locationsv63

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v62

  4. Minor

    Completion date: Dec 29, 2023 to Mar 29, 2024

    Study Statusv61

  5. Minor

    2 amendments

    2 re-verifications since 2023-03-17, no change to tracked fields

    v59-v60

  6. Minor

    Completion date: Dec 30, 2022 to Dec 29, 2023

    Study Statusv58

  7. Minor

    Study sites: 104 to 103

    Study Status, Contacts/Locationsv57

  8. Minor

    Study Status, Study Description

    Re-verified, no change to tracked fields

    v56

  9. Minor

    Site details revised at 2 of 104 sites

    Study Status, Contacts/Locationsv55

  10. Minor

    Completion date: Dec 31, 2021 to Dec 30, 2022

    Start date: Feb 8, 2005 to Feb 13, 2005; Site details revised at 1 of 104 sites

    Study Status, Contacts/Locationsv54

  11. Minor

    2 amendments

    2 re-verifications since 2021-06-11, no change to tracked fields

    v52-v53

  12. Minor

    Study sites: 85 to 104

    Completion date: Mar 31, 2021 to Dec 31, 2021

    Study Status, Contacts/Locationsv51

  13. Minor

    Completion date: Dec 31, 2020 to Mar 31, 2021

    Study Statusv50

  14. Minor

    3 amendments

    3 re-verifications since 2020-03-09, no change to tracked fields

    v47-v49

  15. Minor

    Completion date: Dec 31, 2019 to Dec 31, 2020

    Site details revised at 1 of 85 sites

    Study Status, Contacts/Locationsv46

  16. Minor

    Site details revised at 1 of 85 sites

    Study Status, Contacts/Locationsv45

  17. Minor

    Study sites: 84 to 85

    Study Status, Contacts/Locationsv44

  18. Minor

    Completion date: Jan 2, 2019 to Dec 31, 2019

    Study Statusv43

  19. Minor

    2 amendments

    2 re-verifications since 2018-10-23, no change to tracked fields

    v41-v42

  20. Minor

    Site details revised at 1 of 84 sites

    Study Status, Contacts/Locationsv40

  21. Minor

    Study Status

    Re-verified, no change to tracked fields

    v39

  22. Minor

    Completion date: Jan 5, 2018 to Jan 2, 2019

    Site details revised at 2 of 84 sites

    Study Status, Contacts/Locationsv38

  23. Minor

    Study Status

    Re-verified, no change to tracked fields

    v37

  24. Minor

    Enrollment target: 834 to 736

    Study sites: 75 to 84; Primary completion date: Feb 2009 to Feb 27, 2009; Completion date: Jan 2018 to Jan 5, 2018; and 1 more

    Show all 5 changes in this update
    • Minor Enrollment target: 834 to 736
    • Minor Study sites: 75 to 84
    • Minor Primary completion date: Feb 2009 to Feb 27, 2009
    • Minor Completion date: Jan 2018 to Jan 5, 2018
    • Minor Start date: Feb 2005 to Feb 8, 2005

    Study Status, Study Design, Contacts/Locationsv36

  25. Minor

    Study Status, Baseline Characteristics

    Re-verified, no change to tracked fields

    v35

  26. Minor

    Completion date: Jan 2017 to Jan 2018

    Study Status, Baseline Characteristicsv34

  27. Minor

    4 amendments

    4 re-verifications since 2015-11-02, no change to tracked fields

    v30-v33

  28. Minor

    Completion date: Jan 2016 to Jan 2017

    Study Statusv29

  29. Minor

    3 amendments

    3 re-verifications since 2015-02-18, no change to tracked fields

    v26-v28

  30. Minor

    Completion date: Jan 2015 to Jan 2016

    Study Statusv25

  31. Minor

    Study sites: 86 to 75

    Completion date: Sep 2013 to Jan 2015; Secondary endpoints: 6 to 7

    Show what changed: Secondary endpoints
    TimeChange toFrom DeteriorationRandomisation in Trial Outcome Index (TOI) Over the Course of the Study Overall Survival (OS) - Follow-up

    Study Status, Outcome Measures, Eligibility, Contacts/Locations, References, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Eventsv24

  32. Minor

    Study sites: 88 to 86

    Study Status, Contacts/Locationsv23

  33. Minor

    Site details revised at 2 of 88 sites

    Study Status, Contacts/Locationsv22

  34. Minor

    Study Status, Sponsor/Collaborators, Adverse Events

    Re-verified, no change to tracked fields

    v21

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
727 trials monitored
See 63 trials at risk
Breast Cancer
5,213 trials monitored
See 275 trials at risk
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
Trial Details
NCT Number NCT00099437
Lead Sponsor AstraZeneca
Conditions Breast Cancer
Enrollment 736 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov