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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,240

Participants

Timeline

Start Date

December 27, 2018

Primary Completion Date

January 24, 2031

Study Completion Date

January 24, 2031

Conditions
Breast Cancer
Interventions
BIOLOGICAL

Pembrolizumab (K)

IV infusion Q3W

DRUG

Placebo (P)

Normal saline or dextrose IV infusion Q3W

DRUG

Paclitaxel (X)

IV infusion QW

DRUG

Doxorubicin (A)

IV infusion either in Q2W or Q3W

DRUG

Epirubicin (E)

IV infusion either in Q2W or Q3W

DRUG

Cyclophosphamide (C)

IV infusion either in Q2W or Q3W

DRUG

Endocrine therapy

Variable endocrine therapy for up 10 years

RADIATION

Radiation therapy

Variable radiation therapy per local standard of care

PROCEDURE

Surgery

Surgery for breast cancer

Trial Locations (244)

333

Linkou Chang Gung Memorial Hospital ( Site 2402), Taoyuan District

1032

Budapesti Szent Margit Korhaz ( Site 2901), Budapest

1070

Institut Jules Bordet ( Site 0710), Anderlecht

1122

Orszagos Onkologiai Intezet ( Site 2908), Budapest

1145

Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 2902), Budapest

1200

Cliniques Universitaires Saint-Luc ( Site 0701), Brussels

2050

Chris OBrien Lifehouse ( Site 2107), Camperdown

2065

Royal North Shore Hospital ( Site 2100), Sydney

2145

Westmead Hospital ( Site 2101), Sydney

2650

UZ Antwerpen - Medical Oncology ( Site 0709), Edegem

2820

Imelda Ziekenhuis Bonheiden ( Site 0703), Bonheiden

3000

Peter MacCallum Cancer Centre ( Site 2102), Melbourne

UZ Leuven ( Site 0702), Leuven

3112

Tauranga Hospital ( Site 2302), Tauranga

3199

Frankston Hospital ( Site 2103), Frankston

3500

Jessa Ziekenhuis Campus Virga Jesse ( Site 0704), Hasselt

3526

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

4000

CHC MontLegia ( Site 0707), Liège

4032

Debreceni Egyetem Klinikai Kozpont ( Site 2907), Debrecen

4101

Mater Misericordiae Ltd ( Site 2106), South Brisbane

5530

CHU UCL Namur Site de Godinne ( Site 0706), Yvoir

6000

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 2913), Kecskemét

6021

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

7400

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915), Kaposvár

7621

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905), Pécs

8011

Canterbury Regional Cancer & Blood Services ( Site 2303), Christchurch

8500

AZ Groeninge ( Site 0705), Kortrijk

9000

AZ Maria Middelares Gent ( Site 0700), Ghent

10065

Weill Cornell Medical College ( Site 0043), New York

10408

National Cancer Center ( Site 2204), Goyang-si

10903

Hospital Metropolitano - Sede Lindora ( Site 4203), Santa Ana

11259

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

14076

Centre Francois Baclesse ( Site 0927), Caen

15006

Hospital Teresa Herrera - Chuac ( Site 1358), A Coruña

17822

Geisinger Medical Center ( Site 0052), Danville

19111

Fox Chase Cancer Center ( Site 0078), Philadelphia

19124

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

20817

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

21079

Centre Georges Francois Leclerc ( Site 0920), Dijon

23007

Complejo Hospitalario de Jaen ( Site 1364), Jaén

23114

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

23502

Virginia Oncology Associates ( Site 8001), Norfolk

28007

Hospital General Universitario Gregorio Maranon ( Site 1367), Madrid

Hospital Beata María Ana-oncology ( Site 1370), Madrid

28040

Hospital Clinico San Carlos ( Site 1354), Madrid

28041

Hospital Universitario 12 de Octubre ( Site 1356), Madrid

28223

Hospital Quiron de Madrid ( Site 1351), Pozuelo de Alarcón

29000

Khmelnitskiy Regional Onkology Dispensary ( Site 2704), Khmelnitskiy

29425

Medical University of South Carolina ( Site 0053), Charleston

30177

MVZ Onko Medical GmbH Hannover ( Site 1013), Hanover

30265

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

31059

Institut Claudius Regaud IUCT Oncopole ( Site 0903), Toulouse

32207

Baptist MD Anderson Cancer Center ( Site 0014), Jacksonville

33098

Frauenklinik St. Louise ( Site 1014), Paderborn

34070

Centre de Cancerologie du Grand Montpellier ( Site 0925), Montpellier

36526

Southern Cancer Center, PC ( Site 8003), Daphne

37203

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

40202

James Graham Brown Cancer Center ( Site 0022), Louisville

40447

China Medical University Hospital ( Site 2401), Taichung

41013

Hospital Universitario Virgen del Rocio ( Site 1360), Seville

45136

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

46011

Hospital Clinico Universitario de Valencia ( Site 1355), Valencia

46015

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

46526

Goshen Center for Cancer Care ( Site 0021), Goshen

48202

Henry Ford Health System ( Site 0028), Detroit

49102

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

50030

Rodrigo Botero SAS ( Site 0407), Medellín

50048

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

50702

MercyOne Waterloo Cancer Center ( Site 0016), Waterloo

53111

Gynaekologisches Zentrum ( Site 1003), Bonn

55905

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

57085

CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919), Metz

59000

Centre Oscar Lambret ( Site 0911), Lille

59102

St. Vincent Frontier Cancer Center ( Site 0033), Billings

60077

Orchard Healthcare Research Inc. ( Site 0020), Skokie

60099

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

60637

The University of Chicago Medical Center ( Site 0080), Chicago

61070

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

63011

Centre Jean Perrin ( Site 0909), Clermont-Ferrand

63069

Sana Klinikum Offenbach GmbH ( Site 1002), Offenbach

65025

MI Odesa Regional Clinical Hospital ( Site 2701), Odesa

65055

MI Odessa Regional Oncological Centre ( Site 2714), Odesa

65199

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

66113

Caritas Klinikum Saarbruecken St. Theresia ( Site 1009), Saarbrücken

68130

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

69035

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

70457

National Cheng Kung University Hospital ( Site 2400), Tainan City

72000

Clinique Victor Hugo Le Mans ( Site 0906), Le Mans

73000

"Communal nonprofit enterprise Kherson Regional Oncology Dispensary of Kherson Regional Council ( Site 2713)", Antonivka Village

74133

CTCA Southwestern ( Site 0074), Tulsa

75005

Institut Curie ( Site 0900), Paris

75010

Hopital Saint-Louis ( Site 0908), Paris

75020

Hopital Tenon ( Site 0914), Paris

75075

Texas Oncology- Plano East ( Site 8010), Plano

75231

Texas Oncology-Dallas Presbyterian Hospital ( Site 8002), Dallas

75246

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

75702

Texas Oncology - Northeast Texas ( Site 8006), Tyler

76018

MI Precarpathian Clinical Oncology Center ( Site 2707), Ivano-Frankivsk

76100

Kaplan Medical Center ( Site 1703), Rehovot

77024

Texas Oncology-Memorial City ( Site 8012), Houston

77030

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

78731

Texas Oncology-Austin Central ( Site 8004), Austin

80045

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

80336

Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000), Munich

84918

Institut Sainte Catherine ( Site 0916), Avignon

85338

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

85704

Arizona Oncology Associates PC- HOPE ( Site 8008), Tucson

88045

Medizinische Management GmbH ( Site 1012), Friedrichshafen

90048

Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079), Los Angeles

91054

Universitaetsklinikum Erlangen ( Site 1001), Erlangen

92210

Institut Curie - Centre Rene Huguenin ( Site 0917), Saint-Cloud

94040

El Camino Hospital Cancer Center ( Site 0004), Mountain View

94304

Stanford Cancer Center ( Site 0072), Palo Alto

94800

Institut Gustave Roussy ( Site 0926), Villejuif

95817

UC Davis Comprehensive Cancer Center ( Site 0073), Sacramento

97223

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

97239

OHSU Knight Cancer Institute ( Site 0051), Portland

99208

Medical Oncology Associates (Summit Cancer Centers) ( Site 0066), Spokane

99336

Kadlec Clinic Hematology and Oncology ( Site 0070), Kennewick

99734

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

100021

Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208), Beijing

100225

National Taiwan University Hospital ( Site 2404), Taipei

110221

Centro de Investigacion Clinica del Country ( Site 0402), Bogotá

111221

Fundacion Universitaria Sanitas ( Site 0403), Bogotá

115478

N.N. Blokhin NMRCO ( Site 1908), Moscow

121359

Central Clinical Hospital with outpatient Clinic ( Site 1907), Moscow

125367

Medical Rehabilitation Center ( Site 1912), Moscow

130021

The First Hospital of Jilin University ( Site 3201), Changchun

150081

Harbin Medical University Cancer Hospital ( Site 3200), Harbin

163045

Arkhangelsk Clinical Oncological Dispensary ( Site 1901), Arkhangelsk

195271

Railway Hospital of OJSC ( Site 1913), Saint Petersburg

197758

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900), Saint Petersburg

200025

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

200032

Fudan University Shanghai Cancer Center ( Site 3205), Shanghai

230001

Anhui Provincial Hospital ( Site 3224), Heifei

230002

IMAT S.A.S ( Site 0401), Montería

300060

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

310003

The First Affiliated Hospital of Zhejiang University ( Site 3203), Hangzhou

310014

Zhejiang Provincial People's Hospital ( Site 3225), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 3210), Hangzhou

350001

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

390046

Ryazan Regional Clinical Oncology Dispensary ( Site 1910), Ryazan

410013

Hunan Cancer Hospital ( Site 3214), Changsha

420029

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

430079

Hubei Cancer Hospital ( Site 3211), Wuhan

450008

Henan Cancer Hospital ( Site 3212), Zhengzhou

450054

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909), Ufa

510289

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

634028

Tomsk Scientific Research Institute of Oncology ( Site 1905), Tomsk

710061

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

760042

Clínica Imbanaco S.A.S ( Site 0406), Santiago de Cali

830000

The Affiliated Cancer Hospital of Xinjiang Medical ( Site 3219), Ürümqi

1641101

Holy Family Hospital ( Site 1711), Nazareth

1834111

HaEmek Medical Center ( Site 1712), Afula

2778577

National Cancer Center Hospital East ( Site 2613), Kashiwa

3109601

Rambam Health Care Campus-Oncology Division ( Site 1705), Haifa

4428164

Meir Medical Center ( Site 1710), Kfar Saba

5262000

Chaim Sheba Medical Center. ( Site 1707), Ramat Gan

6423906

Sourasky Medical Center ( Site 1706), Tel Aviv

6789140

Assuta Medical Center ( Site 1709), Tel Aviv

7747629

Assuta Ashdod Public ( Site 1704), Ashdod

8410101

Soroka Medical Center ( Site 1701), Beersheba

9103102

Shaare Zedek Medical Center ( Site 1708), Jerusalem

9112001

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

20560121

Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC3 ( Site 0200), Rio de Janeiro

02114

Massachusetts General Hospital ( Site 0024), Boston

01923

MGH - North Shore Cancer Center ( Site 0081), Danvers

02462

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

07666

Holy Name Medical Center ( Site 0041), Teaneck

74605-070

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

98700-000

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

90035-001

Associacao Hospitalar Moinhos de Vento ( Site 0201), Porto Alegre

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202), Porto Alegre

88034-000

CEPON - Centro de Pesquisas Oncologicas ( Site 0208), Florianópolis

88301-220

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

01317-001

Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204), São Paulo

04014-002

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

12460-000

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

T6G 1Z2

Cross Cancer Institute ( Site 0115), Edmonton

V5Z 4E6

BC Cancer-Vancouver Center ( Site 0116), Vancouver

M5G 2M9

Princess Margaret Cancer Centre ( Site 0112), Toronto

J4V 2H1

CISSS de la Monteregie-Centre ( Site 0108), Greenfield Park

H1T 2M4

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

H2X 3E4

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

H3T 1E2

Jewish General Hospital ( Site 0103), Montreal

G1S 4L8

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

G8Z 3R9

Centre Hospitalier Regional de Trois-Rivieres ( Site 0106), Trois-Rivières

050019

Fourth Hospital Of Hebei Medical University ( Site 3216), Shijiazhuang

050030

Fundacion Colombiana de Cancerología Clinica Vida ( Site 0405), Medellín

080020

Clinica de la Costa S.A.S. ( Site 0400), Barranquilla

01307

Universitaetsklinikum Carl Gustav Carus ( Site 1008), Dresden

T12 DV56

Bon Secours Hospital ( Site 1554), Cork

Dublin 8

St. James s Hospital ( Site 1553), Dublin

4941 492

Rabin Medical Center ( Site 1702), Petah Tikva

464-8681

Aichi Cancer Center ( Site 2601), Nagoya

003-0804

National Hospital Organization Hokkaido Cancer Center ( Site 2607), Sapporo

663-8501

Hyogo Medical University Hospital ( Site 2600), Nishinomiya

252-0375

Kitasato University Hospital ( Site 2616), Sagamihara

860-8556

Kumamoto University Hospital ( Site 2602), Kumamoto

350-1298

Saitama Medical University International Medical Center ( Site 2606), Hidaka

362-0806

Saitama Prefectural Cancer Center ( Site 2612), Kitaadachi-gun

411-8777

Shizuoka Cancer Center ( Site 2611), Suntogun

260-8717

Chiba Cancer Center ( Site 2605), Chiba

960-1295

Fukushima Medical University Hospital ( Site 2610), Fukushima

730-8518

Hiroshima City Hiroshima Citizens Hospital ( Site 2603), Hiroshima

540-0006

National Hospital Organization Osaka National Hospital ( Site 2614), Osaka

105-8470

Toranomon Hospital ( Site 2608), Tokyo

135-8550

Cancer Institute Hospital of JFCR ( Site 2604), Tokyo

142-8666

Showa Medical University Hospital ( Site 2615), Tokyo

85-796

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800), Bydgoszcz

53-413

Dolnoslaskie Centrum Onkologii. ( Site 1820), Wroclaw

07-410

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

02-781

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

05-135

Mazowiecki Szpital Onkologiczny ( Site 1803), Wieliszew

15-027

Bialostockie Centrum Onkologii ( Site 1819), Bialystok

80-219

Wojewodzkie Centrum Onkologii Copernicus ( Site 1817), Gdansk

81-519

Szpitale Pomorskie Sp. z o.o. ( Site 1818), Gdynia

43-300

Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810), Bielsko-Biala

41-900

Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807), Bytom

44-101

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801), Gliwice

93-338

Instytut Centrum Zdrowia Matki Polki ( Site 1821), Lodz

1400-038

Fundacao Champalimaud ( Site 2500), Lisboa

1649-035

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

4099-001

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

4200-072

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

00935

UPR Comprehensive Cancer Center ( Site 6200), San Juan

03080

Seoul National University Hospital ( Site 2200), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 2201), Seoul

05505

Asan Medical Center ( Site 2202), Seoul

06351

Samsung Medical Center ( Site 2203), Seoul

08908

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363), L'Hospitalet de Llobregat

08023

Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352), Barcelona

08035

Hospital Vall D Hebron ( Site 1357), Barcelona

08036

Hospital Clinic I Provincial de Barcelona ( Site 1353), Barcelona

03022

SNPE National Cancer Institute ( Site 2719), Kyiv

03115

Kyiv City Clinical Oncology Centre ( Site 2716), Kyiv

BS2 8ED

University Hospitals Bristol NHS Foundation Trust ( Site 1503), Bristol

NG5 1PF

Nottingham University Hospitals NHS Trust ( Site 1504), Nottingham

CO4 5JL

Colchester General Hospital ( Site 1508), Colchester

EC1A 7BE

Barts Health NHS Trust ( Site 1500), London

SE1 9RY

Guy's Hospital ( Site 1501), London

SW17 0QT

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

B91 2JL

Birmingham & Solihull Heartlands Hospital NHS ( Site 1506), Solihull

TR1 3LJ

Royal Cornwall Hospital ( Site 1502), Truro

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY