Evidence mapPaperPMID 39693591Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition: Results From the Phase III postMONARCH Trial.

Kevin Kalinsky, Giampaolo Bianchini, Erika Hamilton, Stephanie L Graff, Kyong Hwa Park, Rinath Jeselsohn, Umut Demirci, Miguel Martin, Rachel M Layman, Sara A Hurvitz and 13 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 6 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. The Role of Estrogen Receptor-Targeted PET with 16α-Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Pooled it
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  6. Pooled it
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Review
  12. Cancers · 2026
    Review
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  16. Article
  17. Review
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  20. Article

5 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

23 authors.

Kevin KalinskyWinship Cancer Institute at Emory University, Atlanta, GA.ORCID 0000-0002-3113-7902
Giampaolo BianchiniIRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.ORCID 0000-0002-6790-6267
Erika HamiltonSarah Cannon Research Institute, Nashville, TN.ORCID 0000-0002-1911-0336
Stephanie L GraffBrown University Health, Legorreta Cancer Center at Brown University, Providence, RI.ORCID 0000-0003-1928-1722
Kyong Hwa ParkKorea University Anam Hospital, Korea University, Seoul, South Korea.ORCID 0000-0002-2464-7920
Rinath JeselsohnDana-Farber Cancer Institute, Harvard Medical School, Boston, MA.ORCID 0000-0001-7996-7529
Umut DemirciMemorial Ankara Hospital, Ankara, Turkey.
Miguel MartinHospital General Universitario Gregorio Maranon, Universidad Complutense, Madrid, Spain.ORCID 0000-0001-9237-3231
Rachel M LaymanMD Anderson Cancer Center, University of Texas, Houston, TX.ORCID 0000-0002-8663-0331
Sara A HurvitzFred Hutchinson Cancer Center, University of Washington School of Medicine, Seattle, WA.ORCID 0000-0001-7808-7191
Sarah SammonsDana-Farber Cancer Institute, Harvard Medical School, Boston, MA.ORCID 0000-0003-2589-9422
Peter A KaufmanUniversity of Vermont Medical Center, Burlington, VT.ORCID 0000-0003-3677-6807
Montserrat MuñozHospital Clinic and Translational Genomics and Targeted Therapeutics, Institut d'Investigacions Biomediques Pi I Sunyer-IDIBAPS, Barcelona, Spain.ORCID 0000-0001-7772-1437
Jiun-I LaiTaipei Veterans General Hospital, Taipei, Taiwan.
Holly KnodererEli Lilly and Company, Indianapolis, IN.
Cynthia SandovalEli Lilly and Company, Indianapolis, IN.
Aarti R ChawlaEli Lilly and Company, Indianapolis, IN.
Bastien NguyenEli Lilly and Company, Indianapolis, IN.ORCID 0000-0002-6166-4746
Yanhong ZhouEli Lilly and Company, Indianapolis, IN.ORCID 0000-0003-2744-2100
Elizabeth RavenbergEli Lilly and Company, Indianapolis, IN.ORCID 0009-0001-3972-1118
Lacey M LitchfieldEli Lilly and Company, Indianapolis, IN.
Lillian SmythEli Lilly and Company, Indianapolis, IN.ORCID 0000-0002-0986-9285
Seth A WanderMassachusetts General Hospital, Harvard University, Boston, MA.ORCID 0000-0002-4127-4708

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) are the standard first-line treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC); however, disease progression occurs in almost all patients and additional treatment options are needed. Herein, we report outcomes of the postMONARCH trial investigating a switch in ET with/without CDK4/6 inhibition with abemaciclib after disease progression on CDK4/6i.

methodsThis double-blind, randomized phase III study enrolled patients with disease progression on previous CDK4/6i plus aromatase inhibitor as initial therapy for advanced disease or recurrence on/after adjuvant CDK4/6i + ET. Patients were randomly assigned (1:1) to abemaciclib + fulvestrant or placebo + fulvestrant. The primary end point was investigator-assessed progression-free survival (PFS). Secondary end points included PFS by blinded independent central review, objective response rate (ORR), and safety.

resultsThis study randomly assigned 368 patients (abemaciclib + fulvestrant, n = 182 placebo + fulvestrant, n = 186). At the primary analysis (258 events), the hazard ratio (HR) was 0.73 (95% CI, 0.57 to 0.95; nominal

conclusionAbemaciclib + fulvestrant significantly improved PFS after disease progression on previous CDK4/6i + ET in patients with HR+, HER2- ABC, offering an additional targeted therapy option for these patients.

Indexed as

AminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBreast NeoplasmsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6FulvestrantAdultAgedDisease ProgressionDouble-Blind MethodFemaleHumansMiddle AgedProgression-Free SurvivalProtein Kinase InhibitorsabemaciclibAminopyridinesBenzimidazolesCDK4 protein, humanCDK6 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6FulvestrantProtein Kinase Inhibitors

Identifiers

PMID39693591
PMCPMC11936477

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.