deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT03250676

Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

A Phase 1-2 Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

Sponsor: Eisai Inc.

Conditions Breast Adenocarcinoma Breast Cancer Breast Cancer Female Breast Neoplasms Cancer, Breast ER Positive Estrogen Receptor Positive Tumor Estrogen-receptor Positive Breast Cancer
Interventions H3B-6545
Updated 29 times since 2017 Last updated: Feb 4, 2025 Started: Aug 23, 2017 Primary completion: Oct 26, 2023 Completion: Oct 26, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03250676, this PHASE1/PHASE2 trial focuses on Breast Adenocarcinoma and Breast Cancer and remains completed. Sponsored by Eisai Inc., it has been updated 29 times since 2017, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Sep 2017 – ~Jun 2018 · 9 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Feb 2019 · 3 months · monthly snapshot~Feb 2019 – ~Jun 2019 · 4 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Feb 2020 · 4 months · monthly snapshot~Feb 2020 – ~Oct 2020 · 8 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Feb 2022 · 2 months · monthly snapshot~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Dec 2022 · 5 months · monthly snapshot~Dec 2022 – ~Mar 2023 · 3 months · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Jan 2024 · 9 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshot~Mar 2025 – ~Sep 2025 · 6 months · monthly snapshot~Sep 2025 – present · 8 months · monthly snapshot

Change History

29 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Mar 2025 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Sep 2024 — Mar 2025 [monthly]

    Completed PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Jan 2024 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

    Status: Active Not Recruiting → Completed

▶ Show 24 earlier versions

  1. Apr 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Mar 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Dec 2022 — Mar 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  4. Jul 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Jun 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  6. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1_PHASE2

  7. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE1_PHASE2

  8. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE1_PHASE2

  9. Dec 2021 — Feb 2022 [monthly]

    Recruiting PHASE1_PHASE2

  10. Sep 2021 — Dec 2021 [monthly]

    Recruiting PHASE1_PHASE2

  11. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  12. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Active Not Recruiting → Recruiting

  13. Feb 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  14. Oct 2019 — Feb 2020 [monthly]

    Recruiting PHASE1_PHASE2

  15. Aug 2019 — Oct 2019 [monthly]

    Recruiting PHASE1_PHASE2

  16. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE1_PHASE2

  17. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  18. Feb 2019 — Jun 2019 [monthly]

    Recruiting PHASE1_PHASE2

  19. Nov 2018 — Feb 2019 [monthly]

    Recruiting PHASE1_PHASE2

  20. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE1_PHASE2

  21. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE1_PHASE2

  22. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE1_PHASE2

  23. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE1_PHASE2

  24. Sep 2017 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Aug 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eisai Inc.
Data source: Eisai Inc.

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

Study Locations

Angers, France , Ann Arbor, United States , Aurora, United States , Baltimore, United States , Besançon, France , Boston, United States , Cardiff, United Kingdom , Chapel Hill, United States , Chelsea, United Kingdom , Clermont-Ferrand, France and 25 more locations