Evidence map›Paper›PMID 39838117›Full record

Trial reportNature medicine2025

Pembrolizumab and chemotherapy in high-risk, early-stage, ER

Fatima Cardoso, Joyce O'Shaughnessy, Zhenzhen Liu, Heather McArthur, Peter Schmid, Javier Cortes, Nadia Harbeck, Melinda L Telli, David W Cescon, Peter A Fasching and 16 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03725059 (A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative), which is not on this map. Cited by 109 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 2 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.

NCT03725059 phase3active not recruitingnot on this map

A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2018 to 2031Enrolled1,240ConditionsBreast CancerArmsPembrolizumab (K), Placebo (P), Paclitaxel (X), Doxorubicin (A), Epirubicin (E)
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
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  3. Final outcomes of the SOFT and TEXT phase III trials in premenopausal hormone receptor-positive early breast cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
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  11. Pembrolizumab and Paclitaxel in Patients with HR+/HER2- Breast Cancer with HER2-Enriched or Basal-like Subtypes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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49 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

26 authors.

Fatima CardosoBreast Unit, Champalimaud Clinical Centre/Champalimaud Foundation, Lisbon, Portugal. fcardoso@abcglobalalliance.org.ORCID http://orcid.org/0000-0002-6692-2249
Joyce O'ShaughnessyBaylor University Medical Center, Texas Oncology, US Oncology Network, Dallas, TX, USA.
Zhenzhen LiuDepartment of Breast Disease, Henan Breast Cancer Center, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
Heather McArthurUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.ORCID http://orcid.org/0000-0002-0201-3871
Peter SchmidCentre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University London, London, UK.
Javier CortesMedica Scientia Innovation Research, Ridgewood, NJ, USA.ORCID http://orcid.org/0000-0001-7623-1583
Nadia HarbeckBreast Center, Department of OB&GYN, LMU University Hospital, Munich, Germany.ORCID http://orcid.org/0000-0002-9744-7372
Melinda L TelliStanford University School of Medicine, Stanford, CA, USA.ORCID http://orcid.org/0000-0001-7993-1235
David W CesconPrincess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-1080-0998
Peter A FaschingUniversity Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Bavarian Cancer Research Center (BZKF), Erlangen, Germany.
Zhimin ShaoDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Delphine LoiratInstitute Curie, Paris, France.
Yeon Hee ParkSamsung Medical Division, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0003-4156-9212
Manuel Gonzalez FernandezHemato Oncólogo, IMAT Oncomedica, Montería, Colombia.
Gábor RubovszkyNational Institute of Oncology, Budapest, Hungary.
Laura SpringMassachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Seock-Ah ImSeoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-5396-6533
Rina HuiWestmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney, New South Wales, Australia.
Toshimi TakanoThe Cancer Institute Hospital of JFCR, Tokyo, Japan.
Fabrice AndréFaculté de Médecine, Paris Saclay University, Gustave Roussy, Villejuif, France.ORCID http://orcid.org/0000-0001-5795-8357
Hiroyuki YasojimaNHO Osaka National Hospital, Osaka, Japan.
Yu DingMerck & Co., Inc., Rahway, NJ, USA.
Liyi JiaMerck & Co., Inc., Rahway, NJ, USA.
Vassiliki KarantzaMerck & Co., Inc., Rahway, NJ, USA.
Konstantinos TryfonidisMerck & Co., Inc., Rahway, NJ, USA.
Aditya BardiaUniversity of California Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0003-4885-1157

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Addition of pembrolizumab to neoadjuvant chemotherapy followed by adjuvant pembrolizumab improved outcomes in patients with high-risk, early-stage, triple-negative breast cancer. However, whether the addition of neoadjuvant pembrolizumab to chemotherapy would improve outcomes in high-risk, early-stage, estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenAdultAgedCyclophosphamideDouble-Blind MethodDoxorubicinEpirubicinFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm StagingAntibodies, Monoclonal, HumanizedCyclophosphamideDoxorubicinEpirubicinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPaclitaxelpembrolizumabReceptors, Estrogen

Identifiers

PMID39838117
PMCPMC11835712

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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.