Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT02107703

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2)

MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Sponsor: Eli Lilly and Company

Conditions Breast Neoplasms

Interventions Abemaciclib Fulvestrant Placebo

Updated 31 times since 2017 Last updated: Oct 17, 2025 Started: Jul 22, 2014 Primary completion: Feb 14, 2017 Completion: Dec 31, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02107703, this PHASE3 trial focuses on Breast Neoplasms and remains ongoing. Sponsored by Eli Lilly and Company, it has been updated 31 times since 2014, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

31 versions recorded

Nov 2025 — Present [monthly]

Active Not Recruiting PHASE3
Sep 2025 — Nov 2025 [monthly]

Active Not Recruiting PHASE3
May 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE3
Mar 2025 — May 2025 [monthly]

Active Not Recruiting PHASE3
Feb 2025 — Mar 2025 [monthly]

Active Not Recruiting PHASE3

▶ Show 26 earlier versions

Sep 2024 — Feb 2025 [monthly]

Active Not Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Active Not Recruiting PHASE3
Jun 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE3
May 2024 — Jun 2024 [monthly]

Active Not Recruiting PHASE3
Apr 2024 — May 2024 [monthly]

Active Not Recruiting PHASE3
Dec 2023 — Apr 2024 [monthly]

Active Not Recruiting PHASE3
May 2023 — Dec 2023 [monthly]

Active Not Recruiting PHASE3
Dec 2022 — May 2023 [monthly]

Active Not Recruiting PHASE3
Nov 2021 — Dec 2022 [monthly]

Active Not Recruiting PHASE3
Jan 2021 — Nov 2021 [monthly]

Active Not Recruiting PHASE3
Oct 2020 — Jan 2021 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Jul 2020 — Oct 2020 [monthly]

Recruiting PHASE3
Jun 2020 — Jul 2020 [monthly]

Recruiting PHASE3
May 2020 — Jun 2020 [monthly]

Recruiting PHASE3
Apr 2020 — May 2020 [monthly]

Recruiting PHASE3
Mar 2019 — Apr 2020 [monthly]

Recruiting PHASE3

Status: Active Not Recruiting → Recruiting
Feb 2019 — Mar 2019 [monthly]

Active Not Recruiting PHASE3
Nov 2018 — Feb 2019 [monthly]

Active Not Recruiting PHASE3
Sep 2018 — Nov 2018 [monthly]

Active Not Recruiting PHASE3
Jun 2018 — Sep 2018 [monthly]

Active Not Recruiting PHASE3
Mar 2018 — Jun 2018 [monthly]

Active Not Recruiting PHASE3
Jul 2017 — Mar 2018 [monthly]

Active Not Recruiting PHASE3
Mar 2017 — Jul 2017 [monthly]

Active Not Recruiting PHASE3
Feb 2017 — Mar 2017 [monthly]

Active Not Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE3

First recorded

Jul 2014

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

Aalborg, Denmark , Arkhangelsk, Russia , Athens, Greece , Athens, United States , Atlantis, United States , Augsburg, Germany , Baltimore, United States , Barcelona, Spain , Basel, Switzerland , Bayamón, Puerto Rico and 119 more locations