Evidence map›Paper›PMID 32101663›Full record

Trial reportThe New England journal of medicine2020

Pembrolizumab for Early Triple-Negative Breast Cancer.

Peter Schmid, Javier Cortes, Lajos Pusztai, Heather McArthur, Sherko Kümmel, Jonas Bergh, Carsten Denkert, Yeon Hee Park, Rina Hui, Nadia Harbeck and 12 more

15 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 15 registered trials, which are not on this map. Cited by 1,865 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,865citing papers in PubMed, 4 pooled it
136.3field-weighted citation impact, top 1% of its field
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
NCT05132504 phase2recruitingnot on this mapstarted 2022, after this paper: background citation

Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Pembrolizumab Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas

TypeinterventionalSponsorBaylor College of MedicineRan2022 to 2027Enrolled30ConditionsPancreatic Ductal AdenocarcinomaArmsPembrolizumab, Folfirinox
NCT05213312 phase2 / phase3unknown statusnot on this mapstarted 2022, after this paper: background citation

A Randomized, Multicenter, Double Blind, Phase II Study of Neoadjuvant Nivolumab or Placebo Plus Chemotherapy Followed by Surgery and Adjuvant Treatment in Subjects With Resectable Esophageal Squamous Cell Carcinoma

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2022 to 2024Enrolled90ConditionsEsophageal Squamous Cell CarcinomaArmsNivolumab, Cisplatin, Paclitaxel, 5Fluorouracil, Esophagectomy (minimally invasive)
NCT05275777 phase1 / phase2active not recruitingnot on this mapstarted 2022, after this paper: background citation

A Phase Ib Safety lead-in, Followed by Phase II Trial of ADG106 in Combination With Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Stage I-III HER2 Negative Breast Cancer

TypeinterventionalSponsorNational University Hospital, SingaporeRan2022 to 2030Enrolled66ConditionsHER2-negative Breast Cancer, Advanced Solid TumorArmsADG106, Doxorubicin, Cyclophosphamide, Paclitaxel
NCT05763992 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2023 to 2026Enrolled145ConditionsBreast Cancer, Triple Negative Breast Cancer, Dietary Exposure, FastingArmsControl diet (ARM A) or Fasting-Like Approach (FLA, ARM B)
NCT05843292 phase4not yet recruitingnot on this mapstarted 2023, after this paper: background citation

Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer, an Open-labeled, Single Arm Trial

TypeinterventionalSponsorShanghai Jiao Tong University School of MedicineRan2023 to 2034Enrolled48ConditionsTriple-negative Breast CancerArmsTaxane and Carboplatin, Short-term Sintilimab, Surgery
NCT06225284 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Randomized Phase II Study of Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients: ESCALATE Study

TypeinterventionalSponsorNational Taiwan University HospitalRan2024 to 2030Enrolled124ConditionsTriple Negative Breast Cancer, Premenopausal Breast CancerArmsGoserelin Acetate 3.6mg、Goserelin Acetate 10.8mg、Leuprolide Acetate 3.75mg、Leuprorelin Acetate 22.5mg、Triptorelin pamoate 11.25mg、Triptorelin pamoate 22.5mg
NCT06245889 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Pilot Study of Neoadjuvant Response-Adapted Chemotherapy With Pembrolizumab in Patients With Stage 2 and 3 Triple Negative Breast Cancer to Determine Early PET and Biomarker Dynamics

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2024 to 2030Enrolled30ConditionsTriple Negative Breast CancerArmsPaclitaxel, Carboplatin, Pembrolizumab, Doxorubicin, Cyclophosphamide
NCT06497322 nanot yet recruitingnot on this mapstarted 2024, after this paper: background citation

Effectiveness of High-intensity Interval Training During Neoadjuvant Immunochemotherapy on Complete Remission in Patients With Triple-negative Breast Cancer

TypeinterventionalSponsorUniversity Hospital of CologneRan2024 to 2027Enrolled60ConditionsBreast Cancer, Triple Negative Breast CancerArmsExercise intervention - High intensity interval training on a cycle-ergometer
NCT06610097 nawithdrawnnot on this mapstarted 2025, after this paper: background citation

Impacts of Diet, Activity, and Mood on a Dynamic Gut Microbiota During Treatment for Triple-negative Breast Cancer

TypeinterventionalSponsorScripps HealthRan2025 to 2026Enrolled0ConditionsBreast Cancer, Triple Negative Breast Cancer, Early Stage Triple-Negative Breast CarcinomaArmsNutritional Counseling
NCT06638931 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors

TypeinterventionalSponsorInstituto do Cancer do Estado de São PauloRan2024 to 2028Enrolled28ConditionsUrachal Cancer, Parathyroid Carcinoma, Fibrolamellar Carcinoma, AngiosarcomaArmsNivolumab
NCT07007169 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Mediterranean Diet and Inequality in Early Breast Cancer: A Multicenter Randomized Clinical Trial

TypeinterventionalSponsorEsbjerg Hospital - University Hospital of Southern DenmarkRan2025 to 2036Enrolled105ConditionsEarly Breast CancerArmsThe goal is daily consumption of a minimum of 30 grams of dietary fiber and weekly consumption of a minimum of 30 different plant foods, minimizing the amount of ultra-processed food., Standard Diet
NCT07188246 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

A Trial of Neoadjuvant, Hypofractionated Radiation, With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy, in Stage 3 or High-risk Stage 2 Breast Cancer

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2026 to 2029Enrolled40ConditionsBreast Cancer, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer InvasiveArmsRadiation, Pembrolizumab (KEYTRUDA®)
NCT07394387 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Single-Center, Phase II Clinical Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin Neoadjuvant Therapy in Triple-Negative Breast Cancer.

TypeinterventionalSponsorThe First Affiliated Hospital with Nanjing Medical UniversityRan2025 to 2026Enrolled58ConditionsTriple Negative Breast Cancer (TNBC)ArmsSintilimab, Abraxane, Carboplatin, High-intensity focused ultrasound (HIFU)
NCT07644455 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Evaluation of the Accuracy of Vacuum-assisted Percutaneous Biopsy in Predicting Mammary Anatomopathological Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy

TypeinterventionalSponsorInstituto do Cancer do Estado de São PauloRan2026 to 2026Enrolled100ConditionsBreast CancerArmsPre-Neoadjuvant Chemotherapy Clipping, Vacuum-Assisted Biopsy (VAB)
3 · Its place in the literature

Who cites it

1,865 citing papers in PubMed, 4 syntheses or guidelines pooled it, 2,944 citations in OpenAlex.

  1. Pooled it
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  5. Tumor-Infiltrating Lymphocytes as a Predictor of Adjuvant Avelumab Efficacy in Patients with High-risk Triple-Negative Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  18. Inflammatory bowel disease and breast cancer: epidemiological evidence, shared biology, and clinical management.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026
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1,805 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 17 institutions in 11 countries.

Peter SchmidFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Javier CortesFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Lajos PusztaiFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Heather McArthurFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Sherko KümmelFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Jonas BerghFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Carsten DenkertFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Yeon Hee ParkFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).ORCID 0000-0003-4156-9212
Rina HuiFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Nadia HarbeckFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Masato TakahashiFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).ORCID 0000-0002-6641-9598
Theodoros FoukakisFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).ORCID 0000-0001-8952-9987
Peter A FaschingFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Fatima CardosoFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Michael UntchFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Liyi JiaFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Vassiliki KarantzaFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Jing ZhaoFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Gursel AktanFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Rebecca DentFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
Joyce O'ShaughnessyFrom Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Oncology Bureau Institute of Oncology, Quirón Group, Madrid, and Vall d'Hebron Institute of Oncology, Barcelona (J.C.) - both in Spain; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); Cedars-Sinai Medical Center, Los Angeles (H.M.); Kliniken Essen-Mitte, Essen (S.K.), the Institute of Pathology, Philipps-University Marburg and University of Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Ludwig Maximilian University of Munich, University of Munich, Munich (N.H.), University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.), and the Breast Cancer Center, Helios Klinikum Berlin-Buch, Berlin (M.U.) - all in Germany; the Department of Oncology-Pathology, Karolinska Institutet and Breast Cancer Center, Theme Cancer, Karolinska University Hospital, Solna, Sweden (J.B., T.F.); Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (Y.H.P.); Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan (M.T.); the Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal (F.C.); Merck, Kenilworth, NJ (L.J., V.K., J.Z., G.A.); the National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); and Baylor University Medical Center, Texas Oncology and US Oncology, Dallas (J.O.).
KEYNOTE-522 Investigators
Merck & Co., Inc., Rahway, NJ, USA (United States) · USKarolinska University Hospital · SEBreast Center · CHCedars-Sinai Medical Center · USChampalimaud Foundation · PTHelios Hospital Berlin-Buch · DEInstituto Oncológico Dr. Rosell · ESKliniken Essen-Mitte · DENational Hospital Organization Hokkaido Medical Center · JPNational University of Singapore · SGPhilipps University of Marburg · DEQueen Mary University of London · GBSamsung Medical Center · KRTexas Oncology · USThe University of Sydney · AUUniversitätsklinikum Erlangen · DEYale Cancer Center · US

Funding

Merck Sharp and Dohme N/A
6 · The paper itself

Abstract

backgroundPrevious trials showed promising antitumor activity and an acceptable safety profile associated with pembrolizumab in patients with early triple-negative breast cancer. Whether the addition of pembrolizumab to neoadjuvant chemotherapy would significantly increase the percentage of patients with early triple-negative breast cancer who have a pathological complete response (defined as no invasive cancer in the breast and negative nodes) at definitive surgery is unclear.

methodsIn this phase 3 trial, we randomly assigned (in a 2:1 ratio) patients with previously untreated stage II or stage III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) every 3 weeks plus paclitaxel and carboplatin (784 patients; the pembrolizumab-chemotherapy group) or placebo every 3 weeks plus paclitaxel and carboplatin (390 patients; the placebo-chemotherapy group); the two groups then received an additional four cycles of pembrolizumab or placebo, and both groups received doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide. After definitive surgery, the patients received adjuvant pembrolizumab or placebo every 3 weeks for up to nine cycles. The primary end points were a pathological complete response at the time of definitive surgery and event-free survival in the intention-to-treat population.

resultsAt the first interim analysis, among the first 602 patients who underwent randomization, the percentage of patients with a pathological complete response was 64.8% (95% confidence interval [CI], 59.9 to 69.5) in the pembrolizumab-chemotherapy group and 51.2% (95% CI, 44.1 to 58.3) in the placebo-chemotherapy group (estimated treatment difference, 13.6 percentage points; 95% CI, 5.4 to 21.8; P<0.001). After a median follow-up of 15.5 months (range, 2.7 to 25.0), 58 of 784 patients (7.4%) in the pembrolizumab-chemotherapy group and 46 of 390 patients (11.8%) in the placebo-chemotherapy group had disease progression that precluded definitive surgery, had local or distant recurrence or a second primary tumor, or died from any cause (hazard ratio, 0.63; 95% CI, 0.43 to 0.93). Across all treatment phases, the incidence of treatment-related adverse events of grade 3 or higher was 78.0% in the pembrolizumab-chemotherapy group and 73.0% in the placebo-chemotherapy group, including death in 0.4% (3 patients) and 0.3% (1 patient), respectively.

conclusionsAmong patients with early triple-negative breast cancer, the percentage with a pathological complete response was significantly higher among those who received pembrolizumab plus neoadjuvant chemotherapy than among those who received placebo plus neoadjuvant chemotherapy. (Funded by Merck Sharp & Dohme [a subsidiary of Merck]; KEYNOTE-522 ClinicalTrials.gov number, NCT03036488.).

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCyclophosphamideDoxorubicinEpirubicinFemaleHumansIntention to Treat AnalysisKaplan-Meier EstimateMiddle AgedNeoadjuvant TherapyNeoplasm StagingAntibodies, Monoclonal, HumanizedCarboplatinCyclophosphamideDoxorubicinEpirubicinPaclitaxelpembrolizumab

Identifiers

PMID32101663
OpenAlexW3006930853

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