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

Source: https://onco.cc/trials/nct02107703/  
OnCo record `nct02107703` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Abemaciclib and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Eli Lilly and Company, active and no longer recruiting.

## Summary

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer is a phase 3 interventional study registered as NCT02107703 by Eli Lilly and Company, with 669 participants enrolled, started 2014-07-22 and due to reach its primary completion in 2017-02-14. Interventions recorded: Abemaciclib, Fulvestrant and Placebo. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: MONARCH 2
- Tags: pipeline; ctgov-ingest
- Registry id: NCT02107703
- Phase: 3
- Setting: 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
- Enrolled: 669
- Outcomes: Progression-Free Survival (PFS): Abemaciclib + Fulvestrant 16.4 months vs Placebo + Fulvestrant 9.3 months, HR 0.553; Overall Survival (OS): Abemaciclib + Fulvestrant 45.8 months vs Placebo + Fulvestrant 37.25 months; Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]): Abemaciclib + Fulvestrant 35.2% vs Placebo + Fulvestrant 16.1%

## Sources

- ClinicalTrials.gov NCT02107703: https://clinicaltrials.gov/study/NCT02107703

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [CDK4/6 inhibitors](https://onco.cc/technologies/cdk46-inhibitor/), [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/)
- drugs: [Abemaciclib](https://onco.cc/drugs/abemaciclib/), [Fulvestrant](https://onco.cc/drugs/fulvestrant/)
- companies: [Eli Lilly (incl. Loxo)](https://onco.cc/companies/eli-lilly/)
- key papers: [MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy](https://onco.cc/key-papers/paper-nct02107703-j-clin-oncol-2017/), [The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial](https://onco.cc/key-papers/paper-nct02107703-jama-oncol-2020-update/)

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