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)
NCT ID: NCT03725059
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1240 participants
INTERVENTIONAL
2018-12-27
2031-01-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pembrolizumab+Chemotherapy (KX/KA[E]C)
In 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.
Pembrolizumab (K)
IV infusion Q3W
Paclitaxel (X)
IV infusion QW
Doxorubicin (A)
IV infusion either in Q2W or Q3W
Epirubicin (E)
IV infusion either in Q2W or Q3W
Cyclophosphamide (C)
IV infusion either in Q2W or Q3W
Endocrine therapy
Variable endocrine therapy for up 10 years
Radiation therapy
Variable radiation therapy per local standard of care
Surgery
Surgery for breast cancer
Placebo+Chemotherapy (PX/PA[E]C)
In 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.
Placebo (P)
Normal saline or dextrose IV infusion Q3W
Paclitaxel (X)
IV infusion QW
Doxorubicin (A)
IV infusion either in Q2W or Q3W
Epirubicin (E)
IV infusion either in Q2W or Q3W
Cyclophosphamide (C)
IV infusion either in Q2W or Q3W
Radiation therapy
Variable radiation therapy per local standard of care
Surgery
Surgery for breast cancer
Interventions
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Pembrolizumab (K)
IV infusion Q3W
Placebo (P)
Normal saline or dextrose IV infusion Q3W
Paclitaxel (X)
IV infusion QW
Doxorubicin (A)
IV infusion either in Q2W or Q3W
Epirubicin (E)
IV infusion either in Q2W or Q3W
Cyclophosphamide (C)
IV infusion either in Q2W or Q3W
Endocrine therapy
Variable endocrine therapy for up 10 years
Radiation therapy
Variable radiation therapy per local standard of care
Surgery
Surgery for breast cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Southern Cancer Center, PC ( Site 8003)
Daphne, Alabama, United States
Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)
Goodyear, Arizona, United States
Arizona Oncology Associates PC- HOPE ( Site 8008)
Tucson, Arizona, United States
Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)
Los Angeles, California, United States
El Camino Hospital Cancer Center ( Site 0004)
Mountain View, California, United States
Stanford Cancer Center ( Site 0072)
Palo Alto, California, United States
UC Davis Comprehensive Cancer Center ( Site 0073)
Sacramento, California, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 0008)
Aurora, Colorado, United States
Baptist MD Anderson Cancer Center ( Site 0014)
Jacksonville, Florida, United States
Southeastern Regional Medical Center, Inc. ( Site 0075)
Newnan, Georgia, United States
The University of Chicago Medical Center ( Site 0080)
Chicago, Illinois, United States
Orchard Healthcare Research Inc. ( Site 0020)
Skokie, Illinois, United States
Midwestern Regional Medical Center, Inc. ( Site 0077)
Zion, Illinois, United States
Goshen Center for Cancer Care ( Site 0021)
Goshen, Indiana, United States
MercyOne Waterloo Cancer Center ( Site 0016)
Waterloo, Iowa, United States
James Graham Brown Cancer Center ( Site 0022)
Louisville, Kentucky, United States
Maryland Oncology Hematology, P.A. ( Site 8007)
Bethesda, Maryland, United States
Massachusetts General Hospital ( Site 0024)
Boston, Massachusetts, United States
MGH - North Shore Cancer Center ( Site 0081)
Danvers, Massachusetts, United States
MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082)
Newton, Massachusetts, United States
Henry Ford Health System ( Site 0028)
Detroit, Michigan, United States
Mayo Clinic and Medical School (Rochester) ( Site 0029)
Rochester, Minnesota, United States
St. Vincent Frontier Cancer Center ( Site 0033)
Billings, Montana, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039)
Omaha, Nebraska, United States
Holy Name Medical Center ( Site 0041)
Teaneck, New Jersey, United States
Weill Cornell Medical College ( Site 0043)
New York, New York, United States
CTCA Southwestern ( Site 0074)
Tulsa, Oklahoma, United States
OHSU Knight Cancer Institute ( Site 0051)
Portland, Oregon, United States
Northwest Cancer Specialists, P.C. ( Site 8000)
Tigard, Oregon, United States
Geisinger Medical Center ( Site 0052)
Danville, Pennsylvania, United States
Fox Chase Cancer Center ( Site 0078)
Philadelphia, Pennsylvania, United States
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076)
Philadelphia, Pennsylvania, United States
Medical University of South Carolina ( Site 0053)
Charleston, South Carolina, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000)
Nashville, Tennessee, United States
Texas Oncology-Austin Central ( Site 8004)
Austin, Texas, United States
Texas Oncology-Dallas Presbyterian Hospital ( Site 8002)
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009)
Dallas, Texas, United States
Texas Oncology-Memorial City ( Site 8012)
Houston, Texas, United States
University of Texas-MD Anderson Cancer Center ( Site 0083)
Houston, Texas, United States
Texas Oncology- Plano East ( Site 8010)
Plano, Texas, United States
Texas Oncology - Northeast Texas ( Site 8006)
Tyler, Texas, United States
Bon Secours St. Francis Medical Center Oncology Research ( Site 0064)
Midlothian, Virginia, United States
Virginia Oncology Associates ( Site 8001)
Norfolk, Virginia, United States
Kadlec Clinic Hematology and Oncology ( Site 0070)
Kennewick, Washington, United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 0066)
Spokane, Washington, United States
Chris OBrien Lifehouse ( Site 2107)
Camperdown, New South Wales, Australia
Royal North Shore Hospital ( Site 2100)
Sydney, New South Wales, Australia
Westmead Hospital ( Site 2101)
Sydney, New South Wales, Australia
Mater Misericordiae Ltd ( Site 2106)
South Brisbane, Queensland, Australia
Frankston Hospital ( Site 2103)
Frankston, Victoria, Australia
Peter MacCallum Cancer Centre ( Site 2102)
Melbourne, Victoria, Australia
Imelda Ziekenhuis Bonheiden ( Site 0703)
Bonheiden, Antwerpen, Belgium
UZ Antwerpen - Medical Oncology ( Site 0709)
Edegem, Antwerpen, Belgium
Institut Jules Bordet ( Site 0710)
Anderlecht, Bruxelles-Capitale, Region de, Belgium
Cliniques Universitaires Saint-Luc ( Site 0701)
Brussels, Bruxelles-Capitale, Region de, Belgium
CHC MontLegia ( Site 0707)
Liège, Liege, Belgium
Jessa Ziekenhuis Campus Virga Jesse ( Site 0704)
Hasselt, Limburg, Belgium
CHU UCL Namur Site de Godinne ( Site 0706)
Yvoir, Namur, Belgium
AZ Maria Middelares Gent ( Site 0700)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0702)
Leuven, Vlaams-Brabant, Belgium
AZ Groeninge ( Site 0705)
Kortrijk, West-Vlaanderen, Belgium
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205)
Goiânia, Goiás, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)
Ijuí, Rio Grande do Sul, Brazil
Associacao Hospitalar Moinhos de Vento ( Site 0201)
Porto Alegre, Rio Grande do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202)
Porto Alegre, Rio Grande do Sul, Brazil
CEPON - Centro de Pesquisas Oncologicas ( Site 0208)
Florianópolis, Santa Catarina, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207)
Itajaí, Santa Catarina, Brazil
Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC3 ( Site 0200)
Rio de Janeiro, , Brazil
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204)
São Paulo, , Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0210)
São Paulo, , Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209)
São Paulo, , Brazil
Cross Cancer Institute ( Site 0115)
Edmonton, Alberta, Canada
BC Cancer-Vancouver Center ( Site 0116)
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre ( Site 0112)
Toronto, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0108)
Greenfield Park, Quebec, Canada
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111)
Montreal, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114)
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0103)
Montreal, Quebec, Canada
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101)
Québec, Quebec, Canada
Centre Hospitalier Regional de Trois-Rivieres ( Site 0106)
Trois-Rivières, Quebec, Canada
Anhui Provincial Hospital ( Site 3224)
Heifei, Anhui, China
Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215)
Shanghai, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208)
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207)
Fuzhou Fujian, Fujian, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213)
Guangzhou, Guangdong, China
Fourth Hospital Of Hebei Medical University ( Site 3216)
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital ( Site 3200)
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 3212)
Zhengzhou, Henan, China
Hubei Cancer Hospital ( Site 3211)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 3214)
Changsha, Hunan, China
The First Affiliated Hospital of Zhejiang University ( Site 3203)
Hangzhou, Jiangsu, China
The First Hospital of Jilin University ( Site 3201)
Changchun, Jilin, China
Fudan University Shanghai Cancer Center ( Site 3205)
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220)
Xi’an, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital ( Site 3209)
Tianjin, Tianjin Municipality, China
The Affiliated Cancer Hospital of Xinjiang Medical ( Site 3219)
Ürümqi, Xinjiang, China
Zhejiang Provincial People's Hospital ( Site 3225)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 3210)
Hangzhou, Zhejiang, China
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0405)
Medellín, Antioquia, Colombia
Rodrigo Botero SAS ( Site 0407)
Medellín, Antioquia, Colombia
Clinica de la Costa S.A.S. ( Site 0400)
Barranquilla, Atlántico, Colombia
Centro de Investigacion Clinica del Country ( Site 0402)
Bogotá, Bogota D.C., Colombia
Fundacion Universitaria Sanitas ( Site 0403)
Bogotá, Bogota D.C., Colombia
IMAT S.A.S ( Site 0401)
Montería, Departamento de Córdoba, Colombia
Clínica Imbanaco S.A.S ( Site 0406)
Cali, Valle del Cauca Department, Colombia
Hospital Metropolitano - Sede Lindora ( Site 4203)
Santa Ana, Provincia de San José, Costa Rica
Centre Francois Baclesse ( Site 0927)
Caen, Calvados, France
Centre Georges Francois Leclerc ( Site 0920)
Dijon, Cote-d Or, France
Institut Claudius Regaud IUCT Oncopole ( Site 0903)
Toulouse, Haute-Garonne, France
Centre Oscar Lambret ( Site 0911)
Lille, Hauts-de-France, France
Institut Curie - Centre Rene Huguenin ( Site 0917)
Saint-Cloud, Hauts-de-Seine, France
Centre de Cancerologie du Grand Montpellier ( Site 0925)
Montpellier, Herault, France
CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919)
Metz, Moselle, France
Institut Sainte Catherine ( Site 0916)
Avignon, Provence-Alpes-Côte d'Azur Region, France
Centre Jean Perrin ( Site 0909)
Clermont-Ferrand, Puy-de-Dome, France
Clinique Victor Hugo Le Mans ( Site 0906)
Le Mans, Sarthe, France
Institut Gustave Roussy ( Site 0926)
Villejuif, Val-de-Marne, France
Institut Curie ( Site 0900)
Paris, , France
Hopital Saint-Louis ( Site 0908)
Paris, , France
Hopital Tenon ( Site 0914)
Paris, , France
Medizinische Management GmbH ( Site 1012)
Friedrichshafen, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen ( Site 1001)
Erlangen, Bavaria, Germany
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000)
Munich, Bavaria, Germany
Sana Klinikum Offenbach GmbH ( Site 1002)
Offenbach, Hesse, Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004)
Wiesbaden, Hesse, Germany
MVZ Onko Medical GmbH Hannover ( Site 1013)
Hanover, Lower Saxony, Germany
Gynaekologisches Zentrum ( Site 1003)
Bonn, North Rhine-Westphalia, Germany
Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006)
Essen, North Rhine-Westphalia, Germany
Frauenklinik St. Louise ( Site 1014)
Paderborn, North Rhine-Westphalia, Germany
Caritas Klinikum Saarbruecken St. Theresia ( Site 1009)
Saarbrücken, Saarland, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 1008)
Dresden, Saxony, Germany
MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005)
Nordhausen, Thuringia, Germany
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905)
Pécs, Baranya, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904)
Miskolc, Borsod-Abauj Zemplen county, Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2913)
Kecskemét, Bács-Kiskun county, Hungary
Budapesti Szent Margit Korhaz ( Site 2901)
Budapest, , Hungary
Orszagos Onkologiai Intezet ( Site 2908)
Budapest, , Hungary
Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 2902)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 2907)
Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915)
Kaposvár, , Hungary
Bon Secours Hospital ( Site 1554)
Cork, , Ireland
St. James s Hospital ( Site 1553)
Dublin, , Ireland
HaEmek Medical Center ( Site 1712)
Afula, , Israel
Assuta Ashdod Public ( Site 1704)
Ashdod, , Israel
Soroka Medical Center ( Site 1701)
Beersheba, , Israel
Rambam Health Care Campus-Oncology Division ( Site 1705)
Haifa, , Israel
Shaare Zedek Medical Center ( Site 1708)
Jerusalem, , Israel
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700)
Jerusalem, , Israel
Meir Medical Center ( Site 1710)
Kfar Saba, , Israel
Holy Family Hospital ( Site 1711)
Nazareth, , Israel
Rabin Medical Center ( Site 1702)
Petah Tikva, , Israel
Chaim Sheba Medical Center. ( Site 1707)
Ramat Gan, , Israel
Kaplan Medical Center ( Site 1703)
Rehovot, , Israel
Sourasky Medical Center ( Site 1706)
Tel Aviv, , Israel
Assuta Medical Center ( Site 1709)
Tel Aviv, , Israel
Aichi Cancer Center ( Site 2601)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 2613)
Kashiwa, Chiba, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 2607)
Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital ( Site 2600)
Nishinomiya, Hyōgo, Japan
Kitasato University Hospital ( Site 2616)
Sagamihara, Kanagawa, Japan
Kumamoto University Hospital ( Site 2602)
Kumamoto, Kumamoto, Japan
Saitama Medical University International Medical Center ( Site 2606)
Hidaka, Saitama, Japan
Saitama Prefectural Cancer Center ( Site 2612)
Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center ( Site 2611)
Suntogun, Shizuoka, Japan
Chiba Cancer Center ( Site 2605)
Chiba, , Japan
Fukushima Medical University Hospital ( Site 2610)
Fukushima, , Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2603)
Hiroshima, , Japan
National Hospital Organization Osaka National Hospital ( Site 2614)
Osaka, , Japan
Toranomon Hospital ( Site 2608)
Tokyo, , Japan
Cancer Institute Hospital of JFCR ( Site 2604)
Tokyo, , Japan
Showa Medical University Hospital ( Site 2615)
Tokyo, , Japan
Tauranga Hospital ( Site 2302)
Tauranga, Bay of Plenty, New Zealand
Canterbury Regional Cancer & Blood Services ( Site 2303)
Christchurch, Canterbury, New Zealand
Capital & Coast District Health Board - Wellington Hospital ( Site 2301)
Wellington, , New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Dolnoslaskie Centrum Onkologii. ( Site 1820)
Wroclaw, Lower Silesian Voivodeship, Poland
Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814)
Ostrołęka, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1899)
Warsaw, Masovian Voivodeship, Poland
Mazowiecki Szpital Onkologiczny ( Site 1803)
Wieliszew, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 1819)
Bialystok, Podlaskie Voivodeship, Poland
Wojewodzkie Centrum Onkologii Copernicus ( Site 1817)
Gdansk, Pomeranian Voivodeship, Poland
Szpitale Pomorskie Sp. z o.o. ( Site 1818)
Gdynia, Pomeranian Voivodeship, Poland
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810)
Bielsko-Biala, Silesian Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807)
Bytom, Silesian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801)
Gliwice, Silesian Voivodeship, Poland
Instytut Centrum Zdrowia Matki Polki ( Site 1821)
Lodz, Łódź Voivodeship, Poland
Fundacao Champalimaud ( Site 2500)
Lisboa, Aveiro District, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2501)
Lisbon, , Portugal
Unidade Local de Saude de Santo António - Hospital Santo António ( Site 2503)
Porto, , Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502)
Porto, , Portugal
UPR Comprehensive Cancer Center ( Site 6200)
San Juan, , Puerto Rico
Arkhangelsk Clinical Oncological Dispensary ( Site 1901)
Arkhangelsk, Arkhangelskaya oblast, Russia
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909)
Ufa, Baskortostan, Respublika, Russia
N.N. Blokhin NMRCO ( Site 1908)
Moscow, Moscow, Russia
Central Clinical Hospital with outpatient Clinic ( Site 1907)
Moscow, Moscow, Russia
Medical Rehabilitation Center ( Site 1912)
Moscow, Moscow, Russia
Ryazan Regional Clinical Oncology Dispensary ( Site 1910)
Ryazan, Ryazan Oblast, Russia
Railway Hospital of OJSC ( Site 1913)
Saint Petersburg, Sankt-Peterburg, Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900)
Saint Petersburg, Sankt-Peterburg, Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 1903)
Kazan', Tatarstan, Respublika, Russia
Tomsk Scientific Research Institute of Oncology ( Site 1905)
Tomsk, Tomsk Oblast, Russia
National Cancer Center ( Site 2204)
Goyang-si, Kyonggi-do, South Korea
Seoul National University Hospital ( Site 2200)
Seoul, , South Korea
Severance Hospital Yonsei University Health System ( Site 2201)
Seoul, , South Korea
Asan Medical Center ( Site 2202)
Seoul, , South Korea
Samsung Medical Center ( Site 2203)
Seoul, , South Korea
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Teresa Herrera - Chuac ( Site 1358)
A Coruña, La Coruna, Spain
Hospital Quiron de Madrid ( Site 1351)
Pozuelo de Alarcón, Madrid, Spain
Hospital General Universitario Gregorio Maranon ( Site 1367)
Madrid, Madrid, Comunidad de, Spain
Hospital Clinico Universitario de Valencia ( Site 1355)
Valencia, Valenciana, Comunitat, Spain
Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352)
Barcelona, , Spain
Hospital Vall D Hebron ( Site 1357)
Barcelona, , Spain
Hospital Clinic I Provincial de Barcelona ( Site 1353)
Barcelona, , Spain
Complejo Hospitalario de Jaen ( Site 1364)
Jaén, , Spain
Hospital Beata María Ana-oncology ( Site 1370)
Madrid, , Spain
Hospital Clinico San Carlos ( Site 1354)
Madrid, , Spain
Hospital Universitario 12 de Octubre ( Site 1356)
Madrid, , Spain
Hospital Universitario Virgen del Rocio ( Site 1360)
Seville, , Spain
Hospital General Arnau de Vilanova de Valencia ( Site 1369)
Valencia, , Spain
China Medical University Hospital ( Site 2401)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 2400)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 2404)
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403)
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital ( Site 2402)
Taoyuan District, , Taiwan
MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 2702)
Dnipro, Dnipropetrovsk Oblast, Ukraine
MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700)
Kryviy Rih, Dnipropetrovsk Oblast, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 2707)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council ( Site 2713)
Antonivka Village, Kherson Oblast, Ukraine
Khmelnitskiy Regional Onkology Dispensary ( Site 2704)
Khmelnitskiy, Khmelnytskyi Oblast, Ukraine
SNPE National Cancer Institute ( Site 2719)
Kyiv, Kyivska Oblast, Ukraine
MI Odesa Regional Clinical Hospital ( Site 2701)
Odesa, Odesa Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 2714)
Odesa, Odesa Oblast, Ukraine
Medical center of the Limited Liability Company Yulis ( Site 2720)
Zaporizhzhia, Zaporizhzhia Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 2716)
Kyiv, , Ukraine
University Hospitals Bristol NHS Foundation Trust ( Site 1503)
Bristol, Bristol, City of, United Kingdom
Nottingham University Hospitals NHS Trust ( Site 1504)
Nottingham, England, United Kingdom
Colchester General Hospital ( Site 1508)
Colchester, Essex, United Kingdom
Barts Health NHS Trust ( Site 1500)
London, London, City of, United Kingdom
Guy's Hospital ( Site 1501)
London, London, City of, United Kingdom
St. Georges University Hospital NHS Foundation Trust ( Site 1505)
London, London, City of, United Kingdom
Birmingham & Solihull Heartlands Hospital NHS ( Site 1506)
Solihull, , United Kingdom
Royal Cornwall Hospital ( Site 1502)
Truro, , United Kingdom
Countries
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References
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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.
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.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-756
Identifier Type: OTHER
Identifier Source: secondary_id
194604
Identifier Type: REGISTRY
Identifier Source: secondary_id
KEYNOTE-756
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506921-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2080224535
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1294-6352
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-004869-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-756
Identifier Type: -
Identifier Source: org_study_id
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