Evidence map›Paper›PMID 30675515›Full record

ArticleNPJ breast cancer2019

MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer.

Stephen Johnston, Miguel Martin, Angelo Di Leo, Seock-Ah Im, Ahmad Awada, Tammy Forrester, Martin Frenzel, Molly C Hardebeck, Joanne Cox, Susana Barriga and 3 more

2 registry-linked trialsAbstract read
In one paragraph

Article in NPJ breast cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 375 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
375citing papers in PubMed, 11 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02246621 phase3active not recruitingnot on this map

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting

TypeinterventionalSponsorEli Lilly and CompanyRan2014 to 2026Enrolled493ConditionsBreast CancerArmsAbemaciclib, Anastrozole, Letrozole, Placebo
NCT06882499 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Stereotactic Ablative Body Radiotherapy (SABR) With Maintenance of Systemic Therapy Versus Physicians' Choice of Systemic Therapy for Oligoprogressive ER-positive, Her-2 Negative Breast Cancer II

TypeinterventionalSponsorPeter MacCallum Cancer Centre, AustraliaRan2026 to 2032Enrolled74ConditionsBreast Cancer, Metastatic, Metastatic Breast CancerArmsStereotactic Ablative Radiotherapy, Physician's choice of systemic treatment
3 · Its place in the literature

Who cites it

375 citing papers in PubMed, 11 syntheses or guidelines pooled it.

  1. Guideline
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  12. Trial
  13. Imlunestrant with or without abemaciclib in advanced breast cancer: updated efficacy results from the phase III EMBER-3 trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Trial
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  16. A Phase II Study of Abemaciclib for Patients with Retinoblastoma-Positive, Metastatic Triple-Negative Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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315 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Stephen Johnston1Breast Unit, The Royal Marsden NHS Foundation Trust, London, UK.
Miguel Martin2Instituto De Investigacion Sanitaria Gregorio Marañon, Ciberonc, Geicam; Universidad Complutense, Madrid, Spain.
Angelo Di Leo3Department of Oncology, Hospital of Prato, Istituto Toscano Tumori, Prato, Italy.
Seock-Ah Im4Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Ahmad Awada5Oncology Medicine department, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium.
Tammy Forrester6Global Statistical Sciences, Eli Lilly and Company, Indianapolis, IN USA.
Martin Frenzel6Global Statistical Sciences, Eli Lilly and Company, Indianapolis, IN USA.
Molly C Hardebeck7Oncology Clinical Development, Eli Lilly and Company, Indianapolis, IN USA.
Joanne Cox8Oncology Clinical Development, Eli Lilly and Company, Windlesham, UK.
Susana Barriga9Oncology Clinical Development, Eli Lilly and Company, Madrid, Spain.
Masakazu Toi10Department of Breast Surgery, Kyoto University, Kyoto, Japan.
Hiroji Iwata11Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Matthew P Goetz12Department of Oncology, Mayo Clinic, Rochester, MN USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

At the MONARCH 3 interim analysis, abemaciclib plus a nonsteroidal aromatase inhibitor (AI) significantly improved progression-free survival (PFS) and objective response rate (ORR) with a tolerable safety profile as initial treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). MONARCH 3 is a randomized, phase III, double-blind study of abemaciclib/placebo (150 mg twice daily, continuous) plus nonsteroidal AI (1 mg anastrozole or 2.5 mg letrozole, daily). A total of 493 postmenopausal women with HR+, HER2- ABC with no prior systemic therapy in this setting were enrolled. The primary endpoint was investigator-assessed PFS (final analysis after 240 events); other endpoints included response and safety evaluations. Here we analyze the final PFS data and update secondary endpoints. The abemaciclib arm had a significantly longer median PFS than the placebo arm (28.18 versus 14.76 months; hazard ratio [95% confidence interval], 0.540 [0.418-0.698];

Identifiers

PMID30675515
PMCPMC6336880

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.