# MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy

Source: https://onco.cc/key-papers/paper-nct02107703-j-clin-oncol-2017/  
OnCo record `paper-nct02107703-j-clin-oncol-2017` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Published report from the MONARCH 2 trial registered as NCT02107703, in Journal of Clinical Oncology (2017), chosen as the most cited paper whose own text cites the registry id.

## Summary

Purpose MONARCH 2 ( ClinicalTrials.gov identifier: NCT02107703) compared the efficacy and safety of abemaciclib, a selective cyclin-dependent kinase 4 and 6 inhibitor, plus fulvestrant with fulvestrant alone in patients with advanced breast cancer (ABC). Patients and Methods MONARCH 2 was a global, double-blind, phase III study of women with hormone receptor-positive and human epidermal growth factor receptor 2-negative ABC who had progressed while receiving neoadjuvant or adjuvant endocrine therapy (ET), ≤ 12 months from the end of adjuvant ET, or while receiving first-line ET for metastatic disease. Patients were randomly assigned 2:1 to receive abemaciclib or placebo (150 mg twice daily) on a continuous schedule and fulvestrant (500 mg, per label). The primary end point was investigator-assessed progression-free survival (PFS), and key secondary end points included overall survival, objective response rate (ORR), duration of response, clinical benefit rate, quality of life, and safety. Results Between August 2014 and December 2015, 669 patients were randomly assigned to receive abemaciclib plus fulvestrant (n = 446) or placebo plus fulvestrant (n = 223). Abemaciclib plus fulvestrant significantly extended PFS versus fulvestrant alone (median, 16.4 v 9.3 months; hazard ratio, 0.553; 95% CI, 0.449 to 0.681; P <.001). In patients with measurable disease, abemaciclib plus fulvestrant achieved an ORR of 48.1% (95% CI, 42.6% to 53.6%) compared with 21.3% (95% CI, 15.1% to 27.6%) in the control arm. The most common adverse events in the abemaciclib versus placebo arms were diarrhea (86.4% v 24.7%), neutropenia (46.0% v 4.0%), nausea (45.1% v 22.9%), and fatigue (39.9% v 26.9%). Conclusions Abemaciclib at 150 mg twice daily plus fulvestrant was effective, significantly improving PFS and ORR and demonstrating a tolerable safety profile in women with hormone receptor-positive and human epidermal growth factor receptor 2-negative ABC who progressed while receiving ET.

Indexed on Europe PMC as PubMed record 28580882 (DOI 10.1200/jco.2017.73.7585). Its abstract cites the registry id NCT02107703, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Journal of Clinical Oncology
- Year: 2017
- DOI: 10.1200/jco.2017.73.7585
- Authors: Sledge GW, Toi M, Neven P, et al.
- What it means: This is the paper Europe PMC returns for registry id NCT02107703 with the most citations, so it is the natural first reading for anyone following the MONARCH 2 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.

## Sources

- J Clin Oncol 2017: https://doi.org/10.1200/jco.2017.73.7585
- PubMed: https://pubmed.ncbi.nlm.nih.gov/28580882/
- Europe PMC: https://europepmc.org/article/MED/28580882
- ClinicalTrials.gov NCT02107703: https://clinicaltrials.gov/study/NCT02107703

## Connected records

- trials: [A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer](https://onco.cc/trials/nct02107703/)
- journals: [Journal of Clinical Oncology](https://onco.cc/journals/jco/)

---
JSON: https://onco.cc/api/v1/entities/paper-nct02107703-j-clin-oncol-2017.json