AzTrials
AzTrials

Breast CancerPhase 3NCT03725059

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

A Phase 3 study testing Pembrolizumab (K), Paclitaxel (X) and Doxorubicin (A) in people with Breast Cancer, run by Merck Sharp & Dohme LLC at 244 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Pembrolizumab (K), Paclitaxel (X) and Doxorubicin (A)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,240 participants
Where
244 sitesin 24 countries
Study dates
27 Dec 2018to 24 Jan 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is allowed.
  • Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.
  • Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, grade, and PD-L1 status.
  • Note: Sponsor agreement is required for formalin-fixed paraffin-embedded (FFPE) tumor tissue sample or slides that were obtained greater than 60 days prior to the date that the documented informed consent was obtained.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to initiation of study treatment.
  • Male participants must agree to use contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period.
  • Female participants must agree to use effective contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment with pembrolizumab or placebo.
  • Has adequate organ function.

Who cannot join

  • Has a history of non-infectious pneumonitis that required treatment with steroids or has current pneumonitis.
  • Has breast cancer with lobular histology.
  • Has bilateral invasive breast cancer.
  • Has metastatic (Stage IV) breast cancer.
  • Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast).
  • Has any of the following clinical lymph node staging per current American Joint Committee on Cancer (AJCC) staging criteria for breast cancer staging based on radiological and/or clinical assessment: cN3, cN3a, cN3b, or cN3c.
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  • Has ER-, progesterone receptor positive breast cancer.
  • Has undergone excisional biopsy of the primary tumor and/or axillary lymph nodes or has undergone sentinel lymph node biopsy prior to study treatment.
  • Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal breast carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Has a known history of active tuberculosis (Bacillus tuberculosis).
  • Has an active infection requiring systemic therapy.
  • Has left ventricular ejection fraction (LVEF) of <50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.
  • Has other significant cardiac disease, such as: 1) History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the last 6 months. or 2) Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of hepatitis B or known active hepatitis C virus infection.
  • Has received prior treatment for breast cancer.
  • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137).
  • Has received a live vaccine within 30 days prior to the first dose of study treatment.
  • Has severe hypersensitivity (≥Grade 3) to any of the components or excipients used in the study treatments.
  • Is/was enrolled in a study of an investigational agent and received study therapy, or used an investigational device within 4 weeks (12 months for an investigational agent or device with anticancer or antiproliferative properties) prior to the first dose of study treatment.
  • Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment.

Trial locations and contacts

244 sites in 24 countries.

244 sites in 24 countries

United States45 sites

  • University of Colorado, Anschutz Cancer Pavilion ( Site 0008)

    Aurora, Colorado, 80045

  • Texas Oncology-Austin Central ( Site 8004)

    Austin, Texas, 78731

  • Maryland Oncology Hematology, P.A. ( Site 8007)

    Bethesda, Maryland, 20817

  • St. Vincent Frontier Cancer Center ( Site 0033)

    Billings, Montana, 59102

  • Massachusetts General Hospital ( Site 0024)

    Boston, Massachusetts, 02114

  • Medical University of South Carolina ( Site 0053)

    Charleston, South Carolina, 29425

  • The University of Chicago Medical Center ( Site 0080)

    Chicago, Illinois, 60637

  • Texas Oncology-Dallas Presbyterian Hospital ( Site 8002)

    Dallas, Texas, 75231

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009)

    Dallas, Texas, 75246

  • MGH - North Shore Cancer Center ( Site 0081)

    Danvers, Massachusetts, 01923

  • Geisinger Medical Center ( Site 0052)

    Danville, Pennsylvania, 17822

  • Southern Cancer Center, PC ( Site 8003)

    Daphne, Alabama, 36526

  • Henry Ford Health System ( Site 0028)

    Detroit, Michigan, 48202

  • Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)

    Goodyear, Arizona, 85338

  • Goshen Center for Cancer Care ( Site 0021)

    Goshen, Indiana, 46526

  • Texas Oncology-Memorial City ( Site 8012)

    Houston, Texas, 77024

  • University of Texas-MD Anderson Cancer Center ( Site 0083)

    Houston, Texas, 77030

  • Baptist MD Anderson Cancer Center ( Site 0014)

    Jacksonville, Florida, 32207

  • Kadlec Clinic Hematology and Oncology ( Site 0070)

    Kennewick, Washington, 99336

  • Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)

    Los Angeles, California, 90048

  • James Graham Brown Cancer Center ( Site 0022)

    Louisville, Kentucky, 40202

  • Bon Secours St. Francis Medical Center Oncology Research ( Site 0064)

    Midlothian, Virginia, 23114

  • El Camino Hospital Cancer Center ( Site 0004)

    Mountain View, California, 94040

  • Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000)

    Nashville, Tennessee, 37203

  • Weill Cornell Medical College ( Site 0043)

    New York, New York, 10065

  • Southeastern Regional Medical Center, Inc. ( Site 0075)

    Newnan, Georgia, 30265

  • MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082)

    Newton, Massachusetts, 02462

  • Virginia Oncology Associates ( Site 8001)

    Norfolk, Virginia, 23502

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039)

    Omaha, Nebraska, 68130

  • Stanford Cancer Center ( Site 0072)

    Palo Alto, California, 94304

  • Fox Chase Cancer Center ( Site 0078)

    Philadelphia, Pennsylvania, 19111

  • Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076)

    Philadelphia, Pennsylvania, 19124

  • Texas Oncology- Plano East ( Site 8010)

    Plano, Texas, 75075

  • OHSU Knight Cancer Institute ( Site 0051)

    Portland, Oregon, 97239

  • Mayo Clinic and Medical School (Rochester) ( Site 0029)

    Rochester, Minnesota, 55905

  • UC Davis Comprehensive Cancer Center ( Site 0073)

    Sacramento, California, 95817

  • Orchard Healthcare Research Inc. ( Site 0020)

    Skokie, Illinois, 60077

  • Medical Oncology Associates (Summit Cancer Centers) ( Site 0066)

    Spokane, Washington, 99208

  • Holy Name Medical Center ( Site 0041)

    Teaneck, New Jersey, 07666

  • Northwest Cancer Specialists, P.C. ( Site 8000)

    Tigard, Oregon, 97223

  • Arizona Oncology Associates PC- HOPE ( Site 8008)

    Tucson, Arizona, 85704

  • CTCA Southwestern ( Site 0074)

    Tulsa, Oklahoma, 74133

  • Texas Oncology - Northeast Texas ( Site 8006)

    Tyler, Texas, 75702

  • MercyOne Waterloo Cancer Center ( Site 0016)

    Waterloo, Iowa, 50702

  • Midwestern Regional Medical Center, Inc. ( Site 0077)

    Zion, Illinois, 60099

Other trials in United States

China18 sites

  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208)

    Beijing, Beijing Municipality, 100021

  • The First Hospital of Jilin University ( Site 3201)

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital ( Site 3214)

    Changsha, Hunan, 410013

  • Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207)

    Fuzhou Fujian, Fujian, 350001

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213)

    Guangzhou, Guangdong, 510289

  • The First Affiliated Hospital of Zhejiang University ( Site 3203)

    Hangzhou, Jiangsu, 310003

  • Zhejiang Provincial People's Hospital ( Site 3225)

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital ( Site 3210)

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital ( Site 3200)

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital ( Site 3224)

    Heifei, Anhui, 230001

  • Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215)

    Shanghai, Anhui, 200025

  • Fudan University Shanghai Cancer Center ( Site 3205)

    Shanghai, Shanghai Municipality, 200032

  • Fourth Hospital Of Hebei Medical University ( Site 3216)

    Shijiazhuang, Hebei, 050019

  • Tianjin Medical University Cancer Institute & Hospital ( Site 3209)

    Tianjin, Tianjin Municipality, 300060

  • The Affiliated Cancer Hospital of Xinjiang Medical ( Site 3219)

    Ürümqi, Xinjiang, 830000

  • Hubei Cancer Hospital ( Site 3211)

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220)

    Xi’an, Shanxi, 710061

  • Henan Cancer Hospital ( Site 3212)

    Zhengzhou, Henan, 450008

Other trials in China

Japan16 sites

  • Chiba Cancer Center ( Site 2605)

    Chiba, 260-8717

  • Fukushima Medical University Hospital ( Site 2610)

    Fukushima, 960-1295

  • Saitama Medical University International Medical Center ( Site 2606)

    Hidaka, Saitama, 350-1298

  • Hiroshima City Hiroshima Citizens Hospital ( Site 2603)

    Hiroshima, 730-8518

  • National Cancer Center Hospital East ( Site 2613)

    Kashiwa, Chiba, 2778577

  • Saitama Prefectural Cancer Center ( Site 2612)

    Kitaadachi-gun, Saitama, 362-0806

  • Kumamoto University Hospital ( Site 2602)

    Kumamoto, Kumamoto, 860-8556

  • Aichi Cancer Center ( Site 2601)

    Nagoya, Aichi-ken, 464-8681

  • Hyogo Medical University Hospital ( Site 2600)

    Nishinomiya, Hyōgo, 663-8501

  • National Hospital Organization Osaka National Hospital ( Site 2614)

    Osaka, 540-0006

  • Kitasato University Hospital ( Site 2616)

    Sagamihara, Kanagawa, 252-0375

  • National Hospital Organization Hokkaido Cancer Center ( Site 2607)

    Sapporo, Hokkaido, 003-0804

  • Shizuoka Cancer Center ( Site 2611)

    Suntogun, Shizuoka, 411-8777

  • Toranomon Hospital ( Site 2608)

    Tokyo, 105-8470

  • Cancer Institute Hospital of JFCR ( Site 2604)

    Tokyo, 135-8550

  • Showa Medical University Hospital ( Site 2615)

    Tokyo, 142-8666

Other trials in Japan

France14 sites

  • Institut Sainte Catherine ( Site 0916)

    Avignon, Provence-Alpes-Côte d'Azur Region, 84918

  • Centre Francois Baclesse ( Site 0927)

    Caen, Calvados, 14076

  • Centre Jean Perrin ( Site 0909)

    Clermont-Ferrand, Puy-de-Dome, 63011

  • Centre Georges Francois Leclerc ( Site 0920)

    Dijon, Cote-d Or, 21079

  • Clinique Victor Hugo Le Mans ( Site 0906)

    Le Mans, Sarthe, 72000

  • Centre Oscar Lambret ( Site 0911)

    Lille, Hauts-de-France, 59000

  • CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919)

    Metz, Moselle, 57085

  • Centre de Cancerologie du Grand Montpellier ( Site 0925)

    Montpellier, Herault, 34070

  • Institut Curie ( Site 0900)

    Paris, 75005

  • Hopital Saint-Louis ( Site 0908)

    Paris, 75010

  • Hopital Tenon ( Site 0914)

    Paris, 75020

  • Institut Curie - Centre Rene Huguenin ( Site 0917)

    Saint-Cloud, Hauts-de-Seine, 92210

  • Institut Claudius Regaud IUCT Oncopole ( Site 0903)

    Toulouse, Haute-Garonne, 31059

  • Institut Gustave Roussy ( Site 0926)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Spain14 sites

  • Hospital Teresa Herrera - Chuac ( Site 1358)

    A Coruña, La Coruna, 15006

  • Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352)

    Barcelona, 08023

  • Hospital Vall D Hebron ( Site 1357)

    Barcelona, 08035

  • Hospital Clinic I Provincial de Barcelona ( Site 1353)

    Barcelona, 08036

  • Complejo Hospitalario de Jaen ( Site 1364)

    Jaén, 23007

  • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Maranon ( Site 1367)

    Madrid, Madrid, Comunidad de, 28007

  • Hospital Beata María Ana-oncology ( Site 1370)

    Madrid, 28007

  • Hospital Clinico San Carlos ( Site 1354)

    Madrid, 28040

  • Hospital Universitario 12 de Octubre ( Site 1356)

    Madrid, 28041

  • Hospital Quiron de Madrid ( Site 1351)

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario Virgen del Rocio ( Site 1360)

    Seville, 41013

  • Hospital Clinico Universitario de Valencia ( Site 1355)

    Valencia, Valenciana, Comunitat, 46011

  • Hospital General Arnau de Vilanova de Valencia ( Site 1369)

    Valencia, 46015

Other trials in Spain

Israel13 sites

  • HaEmek Medical Center ( Site 1712)

    Afula, 1834111

  • Assuta Ashdod Public ( Site 1704)

    Ashdod, 7747629

  • Soroka Medical Center ( Site 1701)

    Beersheba, 8410101

  • Rambam Health Care Campus-Oncology Division ( Site 1705)

    Haifa, 3109601

  • Shaare Zedek Medical Center ( Site 1708)

    Jerusalem, 9103102

  • Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700)

    Jerusalem, 9112001

  • Meir Medical Center ( Site 1710)

    Kfar Saba, 4428164

  • Holy Family Hospital ( Site 1711)

    Nazareth, 1641101

  • Rabin Medical Center ( Site 1702)

    Petah Tikva, 4941 492

  • Chaim Sheba Medical Center. ( Site 1707)

    Ramat Gan, 5262000

  • Kaplan Medical Center ( Site 1703)

    Rehovot, 76100

  • Sourasky Medical Center ( Site 1706)

    Tel Aviv, 6423906

  • Assuta Medical Center ( Site 1709)

    Tel Aviv, 6789140

Other trials in Israel

Germany12 sites

  • Gynaekologisches Zentrum ( Site 1003)

    Bonn, North Rhine-Westphalia, 53111

  • Universitaetsklinikum Carl Gustav Carus ( Site 1008)

    Dresden, Saxony, 01307

  • Universitaetsklinikum Erlangen ( Site 1001)

    Erlangen, Bavaria, 91054

  • Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006)

    Essen, North Rhine-Westphalia, 45136

  • Medizinische Management GmbH ( Site 1012)

    Friedrichshafen, Baden-Wurttemberg, 88045

  • MVZ Onko Medical GmbH Hannover ( Site 1013)

    Hanover, Lower Saxony, 30177

  • Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000)

    Munich, Bavaria, 80336

  • MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005)

    Nordhausen, Thuringia, 99734

  • Sana Klinikum Offenbach GmbH ( Site 1002)

    Offenbach, Hesse, 63069

  • Frauenklinik St. Louise ( Site 1014)

    Paderborn, North Rhine-Westphalia, 33098

  • Caritas Klinikum Saarbruecken St. Theresia ( Site 1009)

    Saarbrücken, Saarland, 66113

  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004)

    Wiesbaden, Hesse, 65199

Other trials in Germany

Poland12 sites

  • Bialostockie Centrum Onkologii ( Site 1819)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810)

    Bielsko-Biala, Silesian Voivodeship, 43-300

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807)

    Bytom, Silesian Voivodeship, 41-900

  • Wojewodzkie Centrum Onkologii Copernicus ( Site 1817)

    Gdansk, Pomeranian Voivodeship, 80-219

  • Szpitale Pomorskie Sp. z o.o. ( Site 1818)

    Gdynia, Pomeranian Voivodeship, 81-519

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801)

    Gliwice, Silesian Voivodeship, 44-101

  • Instytut Centrum Zdrowia Matki Polki ( Site 1821)

    Lodz, Łódź Voivodeship, 93-338

  • Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814)

    Ostrołęka, Masovian Voivodeship, 07-410

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1899)

    Warsaw, Masovian Voivodeship, 02-781

  • Mazowiecki Szpital Onkologiczny ( Site 1803)

    Wieliszew, Masovian Voivodeship, 05-135

  • Dolnoslaskie Centrum Onkologii. ( Site 1820)

    Wroclaw, Lower Silesian Voivodeship, 53-413

Other trials in Poland

Ukraine11 sites

  • Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council ( Site 2713)

    Antonivka Village, Kherson Oblast, 73000

  • MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 2702)

    Dnipro, Dnipropetrovsk Oblast, 49102

  • MI Precarpathian Clinical Oncology Center ( Site 2707)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721)

    Kharkiv, Kharkiv Oblast, 61070

  • Khmelnitskiy Regional Onkology Dispensary ( Site 2704)

    Khmelnitskiy, Khmelnytskyi Oblast, 29000

  • MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700)

    Kryviy Rih, Dnipropetrovsk Oblast, 50048

  • SNPE National Cancer Institute ( Site 2719)

    Kyiv, Kyivska Oblast, 03022

  • Kyiv City Clinical Oncology Centre ( Site 2716)

    Kyiv, 03115

  • MI Odesa Regional Clinical Hospital ( Site 2701)

    Odesa, Odesa Oblast, 65025

  • MI Odessa Regional Oncological Centre ( Site 2714)

    Odesa, Odesa Oblast, 65055

  • Medical center of the Limited Liability Company Yulis ( Site 2720)

    Zaporizhzhya, Zaporizhzhia Oblast, 69035

Other trials in Ukraine

Belgium10 sites

  • Institut Jules Bordet ( Site 0710)

    Anderlecht, Bruxelles-Capitale, Region de, 1070

  • Imelda Ziekenhuis Bonheiden ( Site 0703)

    Bonheiden, Antwerpen, 2820

  • Cliniques Universitaires Saint-Luc ( Site 0701)

    Brussels, Bruxelles-Capitale, Region de, 1200

  • UZ Antwerpen - Medical Oncology ( Site 0709)

    Edegem, Antwerpen, 2650

  • AZ Maria Middelares Gent ( Site 0700)

    Ghent, Oost-Vlaanderen, 9000

  • Jessa Ziekenhuis Campus Virga Jesse ( Site 0704)

    Hasselt, Limburg, 3500

  • AZ Groeninge ( Site 0705)

    Kortrijk, West-Vlaanderen, 8500

  • UZ Leuven ( Site 0702)

    Leuven, Vlaams-Brabant, 3000

  • CHC MontLegia ( Site 0707)

    Liège, Liege, 4000

  • CHU UCL Namur Site de Godinne ( Site 0706)

    Yvoir, Namur, 5530

Other trials in Belgium

Brazil10 sites

  • CEPON - Centro de Pesquisas Oncologicas ( Site 0208)

    Florianópolis, Santa Catarina, 88034-000

  • Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205)

    Goiânia, Goiás, 74605-070

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)

    Ijuí, Rio Grande do Sul, 98700-000

  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207)

    Itajaí, Santa Catarina, 88301-220

  • Associacao Hospitalar Moinhos de Vento ( Site 0201)

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202)

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC3 ( Site 0200)

    Rio de Janeiro, 20560121

  • Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204)

    São Paulo, 01317-001

  • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210)

    São Paulo, 04014-002

  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209)

    São Paulo, 12460-000

Other trials in Brazil

Russia10 sites

  • Arkhangelsk Clinical Oncological Dispensary ( Site 1901)

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1903)

    Kazan', Tatarstan, Respublika, 420029

  • N.N. Blokhin NMRCO ( Site 1908)

    Moscow, Moscow, 115478

  • Central Clinical Hospital with outpatient Clinic ( Site 1907)

    Moscow, Moscow, 121359

  • Medical Rehabilitation Center ( Site 1912)

    Moscow, Moscow, 125367

  • Ryazan Regional Clinical Oncology Dispensary ( Site 1910)

    Ryazan, Ryazan Oblast, 390046

  • Railway Hospital of OJSC ( Site 1913)

    Saint Petersburg, Sankt-Peterburg, 195271

  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900)

    Saint Petersburg, Sankt-Peterburg, 197758

  • Tomsk Scientific Research Institute of Oncology ( Site 1905)

    Tomsk, Tomsk Oblast, 634028

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909)

    Ufa, Baskortostan, Respublika, 450054

Other trials in Russia

Canada9 sites

  • Cross Cancer Institute ( Site 0115)

    Edmonton, Alberta, T6G 1Z2

  • CISSS de la Monteregie-Centre ( Site 0108)

    Greenfield Park, Quebec, J4V 2H1

  • Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111)

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114)

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital ( Site 0103)

    Montreal, Quebec, H3T 1E2

  • CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101)

    Québec, Quebec, G1S 4L8

  • Princess Margaret Cancer Centre ( Site 0112)

    Toronto, Ontario, M5G 2M9

  • Centre Hospitalier Regional de Trois-Rivieres ( Site 0106)

    Trois-Rivières, Quebec, G8Z 3R9

  • BC Cancer-Vancouver Center ( Site 0116)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Hungary8 sites

  • Budapesti Szent Margit Korhaz ( Site 2901)

    Budapest, 1032

  • Orszagos Onkologiai Intezet ( Site 2908)

    Budapest, 1122

  • Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 2902)

    Budapest, 1145

  • Debreceni Egyetem Klinikai Kozpont ( Site 2907)

    Debrecen, 4032

  • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915)

    Kaposvár, 7400

  • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2913)

    Kecskemét, Bács-Kiskun county, 6000

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904)

    Miskolc, Borsod-Abauj Zemplen county, 3526

  • Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905)

    Pécs, Baranya, 7621

Other trials in Hungary

United Kingdom8 sites

  • University Hospitals Bristol NHS Foundation Trust ( Site 1503)

    Bristol, Bristol, City of, BS2 8ED

  • Colchester General Hospital ( Site 1508)

    Colchester, Essex, CO4 5JL

  • Barts Health NHS Trust ( Site 1500)

    London, London, City of, EC1A 7BE

  • Guy's Hospital ( Site 1501)

    London, London, City of, SE1 9RY

  • St. Georges University Hospital NHS Foundation Trust ( Site 1505)

    London, London, City of, SW17 0QT

  • Nottingham University Hospitals NHS Trust ( Site 1504)

    Nottingham, England, NG5 1PF

  • Birmingham & Solihull Heartlands Hospital NHS ( Site 1506)

    Solihull, B91 2JL

  • Royal Cornwall Hospital ( Site 1502)

    Truro, TR1 3LJ

Other trials in United Kingdom

Colombia7 sites

  • Clinica de la Costa S.A.S. ( Site 0400)

    Barranquilla, Atlántico, 080020

  • Centro de Investigacion Clinica del Country ( Site 0402)

    Bogotá, Bogota D.C., 110221

  • Fundacion Universitaria Sanitas ( Site 0403)

    Bogotá, Bogota D.C., 111221

  • Clínica Imbanaco S.A.S ( Site 0406)

    Cali, Valle del Cauca Department, 760042

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 0405)

    Medellín, Antioquia, 050030

  • Rodrigo Botero SAS ( Site 0407)

    Medellín, Antioquia, 50030

  • IMAT S.A.S ( Site 0401)

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Australia6 sites

  • Chris OBrien Lifehouse ( Site 2107)

    Camperdown, New South Wales, 2050

  • Frankston Hospital ( Site 2103)

    Frankston, Victoria, 3199

  • Peter MacCallum Cancer Centre ( Site 2102)

    Melbourne, Victoria, 3000

  • Mater Misericordiae Ltd ( Site 2106)

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital ( Site 2100)

    Sydney, New South Wales, 2065

  • Westmead Hospital ( Site 2101)

    Sydney, New South Wales, 2145

Other trials in Australia

South Korea5 sites

  • National Cancer Center ( Site 2204)

    Goyang-si, Kyonggi-do, 10408

  • Seoul National University Hospital ( Site 2200)

    Seoul, 03080

  • Severance Hospital Yonsei University Health System ( Site 2201)

    Seoul, 03722

  • Asan Medical Center ( Site 2202)

    Seoul, 05505

  • Samsung Medical Center ( Site 2203)

    Seoul, 06351

Other trials in South Korea

Taiwan5 sites

  • China Medical University Hospital ( Site 2401)

    Taichung, 40447

  • National Cheng Kung University Hospital ( Site 2400)

    Tainan, 70457

  • National Taiwan University Hospital ( Site 2404)

    Taipei, 100225

  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403)

    Taipei, 11259

  • Linkou Chang Gung Memorial Hospital ( Site 2402)

    Taoyuan, 333

Other trials in Taiwan

Portugal4 sites

  • Fundacao Champalimaud ( Site 2500)

    Lisboa, Aveiro District, 1400-038

  • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2501)

    Lisbon, 1649-035

  • Unidade Local de Saude de Santo António - Hospital Santo António ( Site 2503)

    Porto, 4099-001

  • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502)

    Porto, 4200-072

Other trials in Portugal

New Zealand3 sites

  • Canterbury Regional Cancer & Blood Services ( Site 2303)

    Christchurch, Canterbury, 8011

  • Tauranga Hospital ( Site 2302)

    Tauranga, Bay of Plenty, 3112

  • Capital & Coast District Health Board - Wellington Hospital ( Site 2301)

    Wellington, 6021

Other trials in New Zealand

Ireland2 sites

  • Bon Secours Hospital ( Site 1554)

    Cork, T12 DV56

  • St. James s Hospital ( Site 1553)

    Dublin, Dublin 8

Other trials in Ireland

Costa Rica1 site

  • Hospital Metropolitano - Sede Lindora ( Site 4203)

    Santa Ana, Provincia de San José, 10903

Other trials in Costa Rica

Puerto Rico1 site

  • UPR Comprehensive Cancer Center ( Site 6200)

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: 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)

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.

The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

Read the detailed description

Study participants will receive 8 cycles of neoadjuvant study treatment and then will undergo surgery for their breast cancer. After surgery, participants will receive 9 cycles of study treatment and up to 10 years of variable endocrine therapy. Each cycle is 21 days long.

Conditions
Breast Cancer
Being tested
Pembrolizumab (K), Placebo (P), Paclitaxel (X), Doxorubicin (A), Epirubicin (E)
Keywords
PD1, PD-1, PDL1, PD-L1
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab (K)Biological

    Also called MK-3475, KEYTRUDA®

    IV infusion Q3W

  • Placebo (P)Drug

    Normal saline or dextrose IV infusion Q3W

  • Paclitaxel (X)Drug

    Also called TAXOL®

    IV infusion QW

  • Doxorubicin (A)Drug

    Also called ADRIAMYCIN®

    IV infusion either in Q2W or Q3W

  • Epirubicin (E)Drug

    Also called ELLENCE®

    IV infusion either in Q2W or Q3W

  • Cyclophosphamide (C)Drug

    Also called CYTOXAN®

    IV infusion either in Q2W or Q3W

  • Endocrine therapyDrug

    Variable endocrine therapy for up 10 years

  • Radiation therapyRadiation

    Variable radiation therapy per local standard of care

  • SurgeryProcedure or surgery

    Surgery for breast cancer

Study groups in NCT03725059
Study groupRoleWhat they receive
Pembrolizumab+Chemotherapy (KX/KA[E]C)ExperimentalIn the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m^2 or 100 mg/m^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.
Receives: Biological: Pembrolizumab (K); Drug: Paclitaxel (X); Drug: Doxorubicin (A); Drug: Epirubicin (E); Drug: Cyclophosphamide (C); Drug: Endocrine therapy; Radiation: Radiation therapy; Procedure: Surgery
Placebo+Chemotherapy (PX/PA[E]C)Placebo comparatorIn the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m^2 or 100 mg/m^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.
Receives: Drug: Placebo (P); Drug: Paclitaxel (X); Drug: Doxorubicin (A); Drug: Epirubicin (E); Drug: Cyclophosphamide (C); Radiation: Radiation therapy; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0

    The pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pathological Complete Response (pCR) using the definition of (ypT0/Tis ypN0) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.

    Measured: Up to approximately 7 months (Time of surgery)

  2. Event-Free Survival (EFS)

    EFS is defined as the time from randomization to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first. The EFS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies, as determined by the investigator will be presented.

    Measured: Up to approximately 12 years

Secondary outcomes (12)

  1. Overall Survival (OS)

    OS is defined as the time from date of randomization to date of death due to any cause. The OS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies will be presented.

    Measured: Up to approximately 12 years

  2. pCR Rate Using the Definition of ypT0ypN0

    pCR rate (ypT0ypN0) is defined as the percentage of participants without residual invasive or in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the definition of (ypT0ypN0) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.

    Measured: Up to approximately 7 months (Time of surgery)

  3. pCR Rate Using the Definition of ypT0/Tis

    pCR rate (ypT0/Tis) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen (independent of lymph node involvement) after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the definition of ypT0/Tis will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.

    Measured: Up to approximately 7 months (Time of surgery)

  4. pCR Rate Using the Definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 in Participants With a Combined Positive Score [CPS] ≥1

    pCR rates were calculated using the definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 after completion of neoadjuvant systemic therapy by AJCC staging criteria (8th edition) assessed by the local pathologist at the time of surgery. The percentage of participants with a pCR using the three definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 in participants with a CPS ≥1 (with a positive Programmed Cell Death-Ligand 1 [PD-L1] tumor status) will be presented for pembrolizumab versus placebo, both in combination with the protocol-specified neoadjuvant anticancer therapies.

    Measured: Up to approximately 7 months (Time of surgery)

  5. EFS in Participants With a CPS ≥1

    EFS is defined as the time from randomization to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first. The EFS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies, as determined by the investigator for participants with a CPS ≥1 will be presented.

    Measured: Up to approximately 12 years

  6. OS in Participants With a CPS ≥1

    OS is defined as the time from date of randomization to date of death due to any cause. The OS following administration of pembrolizumab and placebo, both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies for participants with a CPS ≥1 will be presented.

    Measured: Up to approximately 12 years

  7. Number of Participants Experiencing an Adverse Event (AE)

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE while receiving pembrolizumab or placebo (including 1 month of safety follow up) will be presented.

    Measured: Up to approximately 15 months

  8. Number of Participants Experiencing a Serious Adverse Event (SAE)

    An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity or Is a congenital anomaly/birth defect. The number of participants who experience an SAE while receiving pembrolizumab or placebo (including 3 months of safety follow up) will be presented.

    Measured: Up to approximately 17 months

  9. Number of Participants Experiencing an Immune-related AE (irAE)

    Some AEs that may occur in this study that are known to be related to pembrolizumab immunotherapy treatment and may include: pneumonitis, diarrhea/colitis, aspartate aminotransferase/alanine aminotransferase (AST/ALT) elevation or increased bilirubin, Type 1 diabetes mellitus or hyperglycemia, hypophysitis, hyperthyroidism, hypothyroidism, nephritis and renal dysfunction, and myocarditis. The number of participants who experience an irAE while receiving pembrolizumab or placebo (including 1 month of safety follow up) will be presented.

    Measured: Up to approximately 15 months

  10. Number of Participants who Discontinued Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment (pembrolizumab or placebo) due to an AE will be presented.

    Measured: Up to approximately 14 months

  11. Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score

    The EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Individual responses for each of 28 items are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome, and responses for each of 2 items (overall health and overall quality of life) are given on a 7-point scale (1=Very poor to 7=Excellent), with a higher score indicating a better outcome. The change from Baseline to end of treatment (up to Cycle 4 Day 1) in EORTC-QLQ-C30 scores for participants will be presented.

    Measured: Baseline (Cycle 1 Day 1 in Treatment 1) and Cycles 1 and 4 Day 1 in Treatment 2 (Up to approximately 5 months) Each cycle is 21 days.

  12. Change from Baseline in EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) Score

    The EORTC QLQ-BR23 is a 23-item questionnaire developed to assess the quality of life in women with breast cancer. Responses for each item are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome. The change from Baseline to end of treatment (up to Cycle 4 Day 1) in EORTC QLQ-BR23 score for participants will be presented.

    Measured: Baseline (Cycle 1 Day 1 in Treatment 1) and Cycles 1 and 4 Day 1 in Treatment 2 (Up to approximately 5 months) Each cycle is 21 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2018
  2. Study start27 Dec 2018
  3. Primary completion24 Jan 2031 (estimated)
  4. Study completion24 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03725059
Sponsor's protocol ID
3475-756
Other IDs
MK-3475-756, 194604, KEYNOTE-756, 2023-506921-12-00, jRCT2080224535, U1111-1294-6352, 2017-004869-27, 2017
Status last verified
Jul 2025
First submitted
29 Oct 2018
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Cardoso F, O'Shaughnessy J, Liu Z, McArthur H, Schmid P, Cortes J, Harbeck N, Telli ML, Cescon DW, Fasching PA, Shao Z, Loirat D, Park YH, Fernandez MG, Rubovszky G, Spring L, Im SA, Hui R, Takano T, Andre F, Yasojima H, Ding Y, Jia L, Karantza V, Tryfonidis K, Bardia A. Pembrolizumab and chemotherapy in high-risk, early-stage, ER+/HER2- breast cancer: a randomized phase 3 trial. Nat Med. 2025 Feb;31(2):442-448. doi: 10.1038/s41591-024-03415-7. Epub 2025 Jan 21.

    PubMed 39838117

  • Schlam I, Corti C, Sammons S, Mittendorf EA, Tolaney SM. Checkpoint inhibition for early-stage hormone receptor-positive breast cancer. Expert Opin Biol Ther. 2024 Jun;24(6):511-520. doi: 10.1080/14712598.2024.2370395. Epub 2024 Jun 24.

    PubMed 38913933

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab (K), Paclitaxel (X) and Doxorubicin (A) in people with Breast Cancer, run by Merck Sharp & Dohme LLC at 244 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 244 sites in United States, China, Japan, France, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 (time frame: Up to approximately 7 months (Time of surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03725059, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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