deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 5-arm NCT03284957

Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer (AMEERA-1)

A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of Amcenestrant (SAR439859), Administered Orally as Monotherapy, Then in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer

Sponsor: Sanofi

Conditions Breast Cancer
Interventions Abemaciclib Alpelisib Amcenestrant Everolimus Palbociclib
Updated 43 times since 2017 Last updated: Nov 6, 2025 Started: Sep 20, 2017 Primary completion: Nov 8, 2024 Completion: Nov 8, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Sponsor decision to prematurely stop the study, not linked to any safety concern.

Other terminated trials from Sanofi

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Other Breast Cancer trials with similar outcome

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Listed as NCT03284957, this PHASE1/PHASE2 trial focuses on Breast Cancer and remains terminated or withdrawn. Sponsored by Sanofi, it has been updated 43 times since 2017, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Oct 2017 – ~Jan 2018 · 3 months · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 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 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~May 2020 · 2 months · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Aug 2020 · 2 months · monthly snapshot~Aug 2020 – ~Nov 2020 · 3 months · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~Jun 2021 · 2 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Mar 2022 · 6 months · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Mar 2024 · 13 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Sep 2025 · 8 months · monthly snapshot~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshot~Dec 2025 – present · 9 months · monthly snapshot

Change History

43 versions recorded

  1. Dec 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Sep 2025 — Dec 2025 [monthly]

    Terminated PHASE1/PHASE2

  3. Jan 2025 — Sep 2025 [monthly]

    Terminated PHASE1/PHASE2

    Status: Active Not Recruiting → Terminated

  4. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

▶ Show 38 earlier versions

  1. Mar 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Feb 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  3. Sep 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  4. Jun 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

  5. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE1_PHASE2

  6. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE1_PHASE2

  7. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE1_PHASE2

  8. Sep 2021 — Mar 2022 [monthly]

    Recruiting PHASE1_PHASE2

  9. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  10. Apr 2021 — Jun 2021 [monthly]

    Recruiting PHASE1_PHASE2

  11. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1_PHASE2

  12. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE1_PHASE2

  13. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  14. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE1_PHASE2

  15. Aug 2020 — Nov 2020 [monthly]

    Recruiting PHASE1_PHASE2

  16. Jun 2020 — Aug 2020 [monthly]

    Recruiting PHASE1_PHASE2

  17. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE1_PHASE2

  18. Mar 2020 — May 2020 [monthly]

    Recruiting PHASE1_PHASE2

  19. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE1_PHASE2

  20. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE1_PHASE2

  21. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE1_PHASE2

  22. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE1_PHASE2

  23. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE1_PHASE2

  24. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE1_PHASE2

  25. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE1_PHASE2

  26. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE1_PHASE2

  27. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  28. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE1_PHASE2

  29. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE1_PHASE2

  30. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE1_PHASE2

  31. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE1_PHASE2

  32. Nov 2018 — Feb 2019 [monthly]

    Recruiting PHASE1_PHASE2

  33. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE1_PHASE2

  34. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE1_PHASE2

  35. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE1_PHASE2

  36. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE1_PHASE2

  37. Jan 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  38. Oct 2017 — Jan 2018 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Sep 2017

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Sanofi
Data source: Sanofi

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

Study Locations

Aurora, United States , Bordeaux, France , Boston, United States , Brno, Czechia , Cardiff, United Kingdom , Edmonton, Canada , Gdynia, Poland , Leuven, Belgium , Lille, France , Lisbon, Portugal and 11 more locations