deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT04436744

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)

A Randomized, Multicenter, Open-Label, Two-Arm, Phase II, Neoadjuvant Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer

Sponsor: Hoffmann-La Roche

Updated 21 times since 2020 Last updated: Jan 9, 2023 Started: Sep 4, 2020 Primary completion: Jul 6, 2021 Completion: Nov 24, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04436744, this PHASE2 trial focuses on Early Breast Cancer and remains completed. Sponsored by Hoffmann-La Roche, it has been updated 21 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Feb 2022 · 2 months · monthly snapshot~Feb 2022 – ~Jul 2022 · 5 months · monthly snapshot~Jul 2022 – ~Mar 2023 · 8 months · monthly snapshot~Mar 2023 – ~Jul 2024 · 16 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 7 months · monthly snapshot

Change History

21 versions recorded
  1. Dec 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2025 — Dec 2025 [monthly]

    Completed PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  5. Mar 2023 — Jul 2024 [monthly]

    Completed PHASE2

Show 16 earlier versions
  1. Jul 2022 — Mar 2023 [monthly]

    Completed PHASE2

  2. Feb 2022 — Jul 2022 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  3. Dec 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  5. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  6. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  7. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE2

  8. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  9. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  10. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2

  11. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  12. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE2

  13. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE2

  14. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  15. Aug 2020 — Sep 2020 [monthly]

    Not Yet Recruiting PHASE2

  16. Jul 2020 — Aug 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hoffmann-La Roche
Data source: Hoffmann-La Roche

For direct contact, visit the study record on ClinicalTrials.gov .