Evidence map›Paper›PMID 41739398›Full record

Trial reportAnnals of surgical oncology2026

Surgical Outcomes After Neoadjuvant Pembrolizumab Plus Chemotherapy for Triple-Negative Breast Cancer: Results from the Randomized, Placebo-Controlled Phase 3 KEYNOTE-522 Study.

Sherko Kuemmel, Peter A Fasching, Peter Schmid, Nadia Harbeck, Masato Takahashi, Michael Untch, Jean-Francois Boileau, Javier Cortes, Rebecca Dent, Joyce O'Shaughnessy and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03036488 (A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer), which is not on this map. Cited by 2 papers.

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

NCT03036488 phase3completednot on this map

A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2017 to 2025Enrolled1,174ConditionsTriple Negative Breast NeoplasmsArmsPembrolizumab, Carboplatin, Paclitaxel, Doxorubicin, Epirubicin
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

20 authors.

Sherko KuemmelBreast Unit, Kliniken Essen-Mitte, Essen, Germany. s.kuemmel@kem-med.com.
Peter A FaschingComprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Erlangen, Germany.
Peter SchmidBarts Cancer Institute, Queen Mary University London, London, UK.
Nadia HarbeckDepartment of Obstetrics and Gynecology, Breast Center, CCC Munich, LMU University Hospital, Munich, Germany.
Masato TakahashiDepartment of Breast Surgery, Hokkaido University Hospital, Sapporo, Japan.
Michael UntchBreast Cancer Center, Helios Klinikum Berlin-Buch, Berlin, Germany.
Jean-Francois BoileauMcGill University, Jewish General Hospital Segal Cancer Centre, Montréal, QC, Canada.
Javier CortesInternational Breast Cancer Center, Pangaea Oncology, Quiron Group, Barcelona, Spain.
Rebecca DentNational Cancer Center Singapore, Duke - National University of Singapore Medical School, Singapore, Singapore.
Joyce O'ShaughnessyTexas Oncology, US Oncology Network, Baylor University Medical Center, Dallas, TX, USA.
Lajos PusztaiYale School of Medicine, Yale Cancer Center, New Haven, CT, USA.
Theodoros FoukakisDepartment of Oncology-Pathology, Karolinska Institutet and Breast Cancer Centre, Cancer Theme, Karolinska University Hospital, Karolinska Comprehensive Cancer Center, Solna, Sweden.
Yeon Hee ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Rina HuiWestmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney, NSW, Australia.
Fatima CardosoChampalimaud Clinical Center/Champalimaud Foundation, Breast Unit, Lisbon, Portugal.
Carsten DenkertInstitute of Pathology, Philipps-University Marburg and University Hospital Marburg, Marburg, Germany.
Liyi JiaMerck & Co., Inc., Rahway, NJ, USA.
Wilbur PanMerck & Co., Inc., Rahway, NJ, USA.
Vassiliki KarantzaMerck & Co., Inc., Rahway, NJ, USA.
Heather McArthurUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe prospectively evaluated surgical outcomes following neoadjuvant pembrolizumab or placebo added to neoadjuvant chemotherapy among participants with early-stage triple-negative breast cancer (TNBC) in the phase 3 KEYNOTE-522 study (NCT03036488).

methodsParticipants with previously untreated, early-stage TNBC (AJCC stage T1c N1-2 or T2-4 N0-2) were randomized 2:1 to neoadjuvant pembrolizumab/placebo plus paclitaxel-carboplatin for 4 cycles, followed by pembrolizumab/placebo plus doxorubicin/epirubicin and cyclophosphamide for 4 cycles. After definitive surgery, participants received adjuvant pembrolizumab/placebo Q3W for 9 cycles. Surgery type and timing, nodal status postsurgery, and adverse events within 30 days following surgery were recorded.

resultsAmong 1,174 randomized participants (pembrolizumab plus chemotherapy, n = 784; placebo plus chemotherapy, n = 390), similar proportions underwent breast-conserving surgery (45.2% vs. 45.6%) and mastectomy (44.0% vs. 42.6%). Median (10th‒90th percentile) time from end of on-study neoadjuvant treatment to surgery was 1.2 (0.9‒1.9) months in the pembrolizumab plus chemotherapy group and 1.2 (0.9‒1.7) months in the placebo plus chemotherapy group. Median (10th‒90th percentile) time from surgery to adjuvant pembrolizumab/placebo was 2.6 (1.0‒3.9) months in the pembrolizumab plus chemotherapy group and 2.7 (1.1‒4.0) months in the placebo plus chemotherapy group. The only AE occurring in ≥5% of participants between 0 and 30 days postsurgery was procedural pain (7.0% vs. 5.8%). The rate of pathological complete nodal response at surgery was 76.7% in the pembrolizumab plus chemotherapy group versus 69.9% in the placebo plus chemotherapy group.

conclusionsThese findings show that adding neoadjuvant pembrolizumab to chemotherapy had no adverse impact on surgical outcomes (including type, timing, and safety). Trial registration ClinicalTrials.gov, NCT03036488 https://www. CLINICALTRIALS: gov/study/NCT03036488.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsMastectomyNeoadjuvant TherapyTriple Negative Breast NeoplasmsAdultAgedAntibodies, Monoclonal, HumanizedCarboplatinCyclophosphamideDoxorubicinEpirubicinFemaleFollow-Up StudiesHumansMiddle AgedPaclitaxelAntibodies, Monoclonal, HumanizedCarboplatinCyclophosphamideDoxorubicinEpirubicinPaclitaxelpembrolizumabBreast-conserving surgeryChemotherapyMastectomyPembrolizumabSurgical outcomesTriple-negative breast cancer

Identifiers

PMID41739398

What OpenQuestion holds

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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.