deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT04568902

Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

A Phase 1 Study of H3B-6545 in Japanese Women With Estrogen Receptor-positive, HER2 Negative Breast Cancer

Sponsor: Eisai Co., Ltd.

Updated 15 times since 2020 Last updated: Oct 22, 2025 Started: Sep 30, 2020 Primary completion: Oct 1, 2025 Completion: Oct 1, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Breast Neoplasms, this trial is completed. The trial is conducted by Eisai Co., Ltd. and has accumulated 15 data snapshots since 2020. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Nov 2021 · 10 months · monthly snapshot~Nov 2021 – ~Feb 2022 · 3 months · monthly snapshot~Feb 2022 – ~Dec 2022 · 10 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Oct 2023 · 9 months · monthly snapshot~Oct 2023 – ~Jan 2024 · 3 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Feb 2025 · 2 months · monthly snapshot~Feb 2025 – ~Sep 2025 · 7 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – present · 6 months · monthly snapshot

Change History

15 versions recorded
  1. Nov 2025 — Present [monthly]

    Completed PHASE1

    Status: Active Not RecruitingCompleted

  2. Sep 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE1

  3. Feb 2025 — Sep 2025 [monthly]

    Active Not Recruiting PHASE1

  4. Dec 2024 — Feb 2025 [monthly]

    Active Not Recruiting PHASE1

  5. Sep 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE1

Show 10 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  2. Jan 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Oct 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Jan 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE1

  5. Dec 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  6. Feb 2022 — Dec 2022 [monthly]

    Recruiting PHASE1

  7. Nov 2021 — Feb 2022 [monthly]

    Recruiting PHASE1

  8. Jan 2021 — Nov 2021 [monthly]

    Recruiting PHASE1

  9. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  10. Oct 2020 — Dec 2020 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Sep 2020

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eisai Co., Ltd.
Data source: Eisai Inc.

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

Study Locations