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Completed PHASE2 INTERVENTIONAL 3-arm NCT02675231

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

Sponsor: Eli Lilly and Company

Conditions HER-2 Positive Breast Cancer Hormone Receptor Positive Breast Cancer
Interventions Abemaciclib Fulvestrant Standard of Care Single Agent Chemotherapy Trastuzumab
Updated 31 times since 2017 Last updated: Nov 4, 2024 Started: May 23, 2016 Primary completion: Apr 8, 2019 Completion: Nov 9, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02675231, this PHASE2 trial focuses on HER-2 Positive Breast Cancer and Hormone Receptor Positive Breast Cancer and remains completed. Sponsored by Eli Lilly and Company, it has been updated 31 times since 2016, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Oct 2017 · 3 months · monthly snapshot~Oct 2017 – ~Feb 2018 · 4 months · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshot~Apr 2019 – ~Aug 2019 · 4 months · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Jun 2020 · 9 months · monthly snapshot~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshot~Sep 2021 – ~Mar 2022 · 6 months · monthly snapshot~Mar 2022 – ~Sep 2022 · 6 months · monthly snapshot~Sep 2022 – ~Oct 2023 · 13 months · monthly snapshot~Oct 2023 – ~Apr 2024 · 6 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Sep 2025 · 9 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 9 months · monthly snapshot

Change History

31 versions recorded

  1. Oct 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2025 — Oct 2025 [monthly]

    Completed PHASE2

  3. Dec 2024 — Sep 2025 [monthly]

    Completed PHASE2

  4. Sep 2024 — Dec 2024 [monthly]

    Completed PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

▶ Show 26 earlier versions

  1. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Oct 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE2

  3. Sep 2022 — Oct 2023 [monthly]

    Active Not Recruiting PHASE2

  4. Mar 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2

  5. Sep 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE2

  6. Mar 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE2

  7. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE2

  8. Jun 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

  9. Sep 2019 — Jun 2020 [monthly]

    Active Not Recruiting PHASE2

  10. Aug 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE2

  11. Apr 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE2

  12. Feb 2019 — Apr 2019 [monthly]

    Active Not Recruiting PHASE2

  13. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE2

  14. Dec 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE2

  15. Nov 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE2

  16. Oct 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE2

  17. Sep 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE2

  18. Jul 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE2

  19. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE2

  20. Mar 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  21. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE2

  22. Oct 2017 — Feb 2018 [monthly]

    Recruiting PHASE2

  23. Jul 2017 — Oct 2017 [monthly]

    Recruiting PHASE2

  24. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE2

  25. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE2

  26. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

May 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eli Lilly and Company
Data source: Eli Lilly and Company

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

Study Locations

Achaia, Greece , Angers, France , Athens, Greece , Atlanta, United States , Badajoz, Spain , Bakersfield, United States , Barcelona, Spain , Besançon, France , Billings, United States , Boston, United States and 65 more locations