Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk,... | NCT04109066 | Trialant

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk,... | NCT04109066 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes the following combined primary tumor and clinical node (cN) categories: T1c (tumor size = 2 cm)-T2 (tumor size > 2 cm), cN1-N2 OR T3-T4, cN0-cN2. Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy.

Estrogen receptor-positive (ER+) breast cancer (BC) and with or without progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample, tested locally, and confirmed by the central laboratory), as defined in the relevant American Society of Clinical Oncology (ASCO)- College of American Pathologists (CAP) Guidelines.

Human epidermal growth factor receptor 2 (HER2-) BC tested in the local laboratory, defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+.

Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10%

Must agree to provide primary breast tumor tissue at baseline and at surgery

Must be deemed eligible for surgery

Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial

Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1

Exclusion Criteria:

Breastfeeding, pregnant, or expecting to conceive or father children within the projected duration of the study, starting with the screening through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study treatment

Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to enrollment

Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Significant cardiovascular disease such as left ventricular ejection fraction (LVEF) < 50% at baseline as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease as described by the New York Heart Association

History of ipsilateral invasive BC, regardless of treatment, ipsilateral ductal carcinoma in situ treated with radiation, or contralateral invasive BC, at any time

Definitive clinical or radiologic evidence of metastatic disease

Multicentric BC (the presence of > 1 tumor in different quadrants of the breast)

Bilateral invasive BC

Other protocol-defined inclusion/exclusion criteria apply

Local Institution - 0136

Mobile, Alabama 36604, United States

Local Institution - 0052

Greenbrae, California 94904, United States

Local Institution - 0051

Whittier, California 90603, United States

Local Institution - 0182

Stamford, Connecticut 06904, United States

Local Institution - 0150

Jacksonville, Florida 32256, United States

Local Institution - 0097

Miami, Florida 33136, United States

Local Institution - 0149

Pensacola, Florida 32504, United States

Local Institution - 0120

Tallahassee, Florida 32308, United States

Local Institution - 0054

Athens, Georgia 30607, United States

Local Institution - 0107

Atlanta, Georgia 30342, United States

Local Institution - 0056

Columbus, Georgia 31904, United States

Local Institution - 0221

Chicago, Illinois 60611, United States

Local Institution - 0227

Fort Wayne, Indiana 46804, United States

Local Institution - 0222

Topsham, Maine 04086, United States

Local Institution - 0146

Bethesda, Maryland 20817, United States

HCA Midwest Division

Kansas City, Missouri 64132, United States

Local Institution - 0109

Florham Park, New Jersey 07932, United States

Local Institution - 0050

Hackensack, New Jersey 07601, United States

Local Institution - 0180

New Brunswick, New Jersey 08903, United States

Local Institution - 0181

Albuquerque, New Mexico 87131, United States

Local Institution - 0041

The Bronx, New York 10461, United States

Local Institution - 0283

Charlotte, North Carolina 28204, United States

Duke Cancer Institute

Durham, North Carolina 27710, United States

Local Institution - 0053

Cleveland, Ohio 44109, United States

Local Institution - 0218

Nashville, Tennessee 37203, United States

Local Institution - 0121

Fort Worth, Texas 76104, United States

Local Institution - 0224

Fairfax, Virginia 22031, United States

Local Institution - 0122

Fredericksburg, Virginia 22408, United States

Virginia Cancer Institute

Richmond, Virginia 23230, United States

Local Institution - 0274

Seattle, Washington 98109, United States

Local Institution - 0012

Ciudad Autonoma Beunos Aires, Buenos Aires 1431, Argentina

Local Institution - 0015

La Plata, Buenos Aires 1900, Argentina

Local Institution - 0020

Buenos Aires, Buenos Aires F.D. C1417DTB, Argentina

Local Institution - 0294

Córdoba, Córdoba Province X5000FHP, Argentina

Local Institution - 0303

Río Cuarto, Córdoba Province 5800, Argentina

Local Institution - 0013

Buenos Aires, Distrito Federal 0, Argentina

Local Institution - 0011

Caba, Distrito Federal 1430, Argentina

Local Institution - 0008

Capital Federal, Distrito Federal C1280AEB, Argentina

Local Institution - 0014

Rosario Santa Fe, Santa Fe Province S2002KDS, Argentina

Local Institution - 0021

Córdoba, X5000BAL, Argentina

Local Institution

La Rioja, Argentina

Local Institution

Viedma, Argentina

Local Institution - 0071

North Sydney, New South Wales 2060, Australia

Local Institution - 0069

Port Macquarie, New South Wales 2444, Australia

Local Institution - 0072

Herston, Queensland 4029, Australia

Local Institution - 0067

Elizabeth Vale, South Australia 5112, Australia

Local Institution - 0066

Clayton, Victoria 3168, Australia

Local Institution - 0142

Clayton, Victoria 3168, Australia

Local Institution - 0070

Melbourne, Victoria 3000, Australia

Local Institution - 0068

North Ballarat, Victoria 33500, Australia

Local Institution - 0045

Graz, 8036, Austria

Local Institution - 0042

Innsbruck, 6020, Austria

Local Institution - 0048

Salzburg, 5020, Austria

Local Institution - 0046

Vienna, 1090, Austria

Local Institution - 0047

Vienna, 1090, Austria

Local Institution - 0187

Brussels, 1090, Belgium

Local Institution - 0030

Charleroi, 6000, Belgium

Local Institution - 0037

Edegem, 2650, Belgium

Local Institution - 0032

Ghent, 9000, Belgium

Local Institution - 0031

Liège, 4000, Belgium

Local Institution - 0130

Fortaleza, Ceará 60135-237, Brazil

Local Institution - 0225

Brasília, Federal District 70200-730, Brazil

Local Institution - 0287

Goiânia, Goiás 74605070, Brazil

Local Institution - 0133

Belo Horizonte, Minas Gerais 30130-100, Brazil

Local Institution - 0132

Ijuí, Rio Grande do Sul 98700-000, Brazil

Local Institution - 0288

Porto Alegre, Rio Grande do Sul 90035-001, Brazil

Local Institution - 0131

Porto Alegre, Rio Grande do Sul 90050-170, Brazil

Local Institution - 0135

Porto Alegre, Rio Grande do Sul 90610-000, Brazil

Local Institution - 0273

Santa Cruz do Sul, Rio Grande do Sul 96830-180, Brazil

Local Institution - 0134

Barretos, São Paulo 14784-400, Brazil

Local Institution - 0128

Santo André, São Paulo 09060-870, Brazil

Local Institution - 0272

São Paulo, São Paulo 01229-010, Brazil

Local Institution - 0129

Rio de Janeiro, 22793-080, Brazil

Local Institution - 0144

São Paulo, 01317-000, Brazil

Local Institution - 0104

São Paulo, 04378-500, Brazil

Local Institution - 0095

Montreal, Quebec H2X 0C1, Canada

Local Institution - 0194

Montreal, Quebec H3T 1E2, Canada

Local Institution - 0058

Sherbrooke, Quebec J1H 5N4, Canada

Local Institution - 0197

La Serena, Coquimbo Region 1720430, Chile

Local Institution - 0016

Santiago, Santiago Metropolitan 0, Chile

Local Institution - 0318

Santiago, Santiago Metropolitan 6900941, Chile

Local Institution - 0019

Santiago Region Metropolitana, Santiago Metropolitan 8330034, Chile

Local Institution - 0018

Viña del Mar, Valparaiso 2520598, Chile

Local Institution - 0326

Antofagasta, Chile

Local Institution - 0235

Bengbu, Anhui 233004, China

Local Institution - 0239

Hefei, Anhui 230031, China

Local Institution

Beijing, Beijing Municipality 100021, China

Local Institution - 0319

Chongqing, Chongqing Municipality 400016, China

Local Institution - 0232

Chongqing, Chongqing Municipality 400030, China

Local Institution - 0267

Guangzhou, Guangdong 510060, China

Local Institution - 0241

Guangzhou, Guangdong 510080, China

Local Institution

Guangzhou, Guangdong 510515, China

Local Institution - 0312

Zunyi, Guizhou 563000, China

Local Institution - 0240

Shjiazhuang, Hebei 50051, China

Local Institution - 0250

Wuhan, Hebei 430022, China

Local Institution - 0248

Harbin, Heilongjiang 150001, China

Local Institution

Zhengzhou, Henan, China

Local Institution - 0255

Changchun, Jilin 130012, China

Local Institution - 0247

Changchun, Jilin 130021, China

Local Institution - 0252

Shenyang, Liaoning 110042, China

Local Institution - 0263

Xi'an, Shan3xi 710061, China

Local Institution - 0245

Jinan, Shandong 250117, China

Local Institution - 0256

Qingdao, Shandong 266000, China

Local Institution - 0214

Yantai, Shandong 264000, China

Local Institution - 0127

Shanghai, Shanghai Municipality 200032, China

Local Institution - 0244

Chengdu, Sichuan 610041, China

Local Institution - 0254

Tianjin, Tianjin Municipality 300060, China

Local Institution - 0311

Ürümqi, Xinjiang 830000, China

Local Institution - 0238

Hangzhou, Zhejiang 310000, China

Local Institution - 0231

Hangzhou, Zhejiang 310003, China

Local Institution - 0237

Hangzhou, Zhejiang 310009, China

Local Institution - 0215

Beijing, 100044, China

Local Institution - 0261

Barranquilla, Atlántico 080020, Colombia

Local Institution - 0094

Bogotá, Bogota D.C. 110221, Colombia

Local Institution - 0203

Colombia, Bogota D.C. 0, Colombia

Local Institution - 0113

Montería, Departamento de Córdoba 230002, Colombia

Local Institution - 0098

Piedecuesta, Santander Department 681017, Colombia

Local Institution - 0093

Cali, 0, Colombia

Local Institution - 0271

Pereira, 660004, Colombia

Local Institution - 0202

Rionegro, 054047, Colombia

Local Institution - 0100

Hradec Králové, 500 05, Czechia

Local Institution - 0103

Nový Jičín, 741 01, Czechia

Local Institution - 0101

Olomouc, 779 00, Czechia

Local Institution - 0099

Prague, 100 34, Czechia

Local Institution - 0167

Aarhus N, Central Jutland 8200, Denmark

Local Institution - 0165

Herlev, 2730, Denmark

Local Institution - 0164

København Ø, 2100, Denmark

Local Institution - 0166

Næstved, 4700, Denmark

Local Institution - 0001

Helsinki, 00029, Finland

Local Institution - 0160

Tampere, 33521, Finland

Local Institution - 0216

Le Mans, Sarthe 72000, France

Local Institution - 0004

Besançon, 25030, France

Local Institution - 0024

Brest, 29200, France

Local Institution - 0162

Clermont-Ferrand, 63011, France

Local Institution - 0153

Lyon, 69000, France

Local Institution - 0152

Montpellier, 34298, France

Local Institution - 0161

Paris, 75908, France

Local Institution - 0195

Plérin, 22190, France

Local Institution - 0002

Saint-Herblain, 44805, France

Local Institution - 0258

Strasbourg, 67085, France

Local Institution - 0228

Toulon, 83056, France

Local Institution - 0003

Villejuif, 94800, France

Local Institution - 0084

München, Bavaria 80337, Germany

Local Institution - 0079

Saarbrücken, Saarland 66113, Germany

Local Institution - 0083

Berlin, 13125, Germany

Local Institution - 0080

Cologne, 50937, Germany

Local Institution - 0112

Dresden, 01307, Germany

Local Institution - 0081

Essen, 45147, Germany

Local Institution - 0158

Frankfurt, 60590, Germany

Local Institution - 0223

Hamburg, 20259, Germany

Local Institution - 0087

Heidelberg, 69126, Germany

Local Institution - 0089

Homburg, 66421, Germany

Local Institution - 0196

Leipzig, 04103, Germany

Local Institution - 0111

Mönchengladbach, 41061, Germany

Local Institution - 0156

Rostock, 18059, Germany

Local Institution - 0157

Velbert, 42551, Germany

Local Institution - 0105

Würzburg, 97080, Germany

Local Institution - 0115

Hong Kong, 0, Hong Kong

Local Institution - 0034

Dublin, Dublin, Ireland

Local Institution - 0035

Beaumont, Dublin 9, Ireland

Local Institution - 0036

Cork, Ireland

Local Institution - 0191

Catanzaro, 88100, Italy

Local Institution - 0207

Milan, 20141, Italy

Azienda Ospedaliero Universitaria Federico II di Napoli

Naples, 80131, Italy

Local Institution - 0124

Naples, 80131, Italy

Local Institution - 0155

Padova, 35128, Italy

Fondazione Irccs - Policlinico San Matteo

Pavia, 27100, Italy

Local Institution - 0190

Roma, 00128, Italy

Local Institution - 0125

Rozzano (MI), 20089, Italy

Local Institution - 0262

Tijuana, Estado de Baja California 22010, Mexico

Local Institution - 0330

Zapopan, Jalisco 45070, Mexico

Local Institution - 0168

Mexico City, Mexico City 03100, Mexico

Local Institution - 0154

Mexico City, Mexico City 14080, Mexico

Local Institution - 0137

Monterrey, Nuevo León 64320, Mexico

Local Institution - 0212

Mérida, Yucatán 97125, Mexico

Local Institution - 0280

Campeche, 24050, Mexico

Local Institution - 0091

Chihuahua City, 31000, Mexico

Local Institution - 0145

Colima, 28018, Mexico

Local Institution - 0141

Oaxaca City, 68020, Mexico

Local Institution - 0033

Amsterdam, 1066 CX, Netherlands

Local Institution - 0177

Breda, 4818CK, Netherlands

Local Institution - 0199

Deventer, 7416 SE, Netherlands

Local Institution - 0147

Utrecht, 3584 CX, Netherlands

Local Institution - 0334

Gliwice, Silesian Voivodeship 44-102, Poland

Local Institution - 0335

Bydgoszcz, 85796, Poland

Local Institution - 0061

Koszalin, 75-581, Poland

Local Institution - 0059

Krakow, 30-688, Poland

Local Institution - 0063

Lodz, 93-338, Poland

Local Institution - 0062

Opole, 45-061, Poland

Local Institution - 0060

Warsaw, 02-781, Poland

Local Institution - 0210

Lisbon, 1500-650, Portugal

Local Institution - 0211

Lisbon, 1649-035, Portugal

Local Institution - 0209

Porto, 4200, Portugal

Local Institution - 0110

Ponce, 00716-0200, Puerto Rico

Local Institution - 0029

Bucharest, 011171, Romania

Local Institution - 0025

Bucharest, 022328, Romania

Local Institution - 0270

Bucharest, 022328, Romania

Local Institution - 0028

Craiova, 200542, Romania

Local Institution - 0027

Floreşti, 407280, Romania

Local Institution - 0026

Suceava, 720237, Romania

Local Institution

Krasnodar, 350040, Russia

Local Institution - 0119

Moscow, 115478, Russia

Local Institution

Moscow, 125367, Russia

Local Institution - 0285

Moskva, 111123, Russia

Local Institution

Ryazan, 390011, Russia

Local Institution - 0306

Saint Petersburg, 194107, Russia

Local Institution - 0284

Saint Petersburg, 197758, Russia

Local Institution

Sochi, 354057, Russia

Local Institution - 0078

Singapore, 119228, Singapore

Local Institution - 0076

Singapore, 168583, Singapore

Local Institution - 0077

Singapore, 308442, Singapore

Local Institution - 0325

Seongnam, 13620, South Korea

Local Institution - 0295

Seoul, 03080, South Korea

Local Institution - 0320

Seoul, 03722, South Korea

Local Institution - 0290

Seoul, 05505, South Korea

Local Institution - 0291

Seoul, 06351, South Korea

Local Institution - 0205

Elche, Alicante 03203, Spain

Local Institution - 0171

Barcelona, 08035, Spain

Local Institution - 0172

Barcelona, 08036, Spain

Local Institution - 0173

Madrid, 28040, Spain

Local Institution - 0176

Madrid, 28050, Spain

Local Institution - 0169

Málaga, 29010, Spain

Local Institution - 0204

Pamplona, 31008, Spain

Local Institution - 0174

Santiago de Compostela, 15706, Spain

Local Institution - 0170

Seville, 41013, Spain

Local Institution - 0175

Valencia, 46010, Spain

Local Institution - 0184

Basel, 4031, Switzerland

Local Institution - 0186

Lausanne, 1011, Switzerland

Local Institution - 0185

Thun, 3600, Switzerland

Local Institution - 0301

Kaohsiung City, 807, Taiwan

Local Institution - 0298

Tainan, 70457, Taiwan

Local Institution - 0300

Tainan, 71004, Taiwan

Local Institution - 0305

Taipei, 10449, Taiwan

Local Institution - 0297

Taipei, 11217, Taiwan

Local Institution - 0073

Adana, 01060, Turkey (Türkiye)

Local Institution - 0257

Ankara, 06520, Turkey (Türkiye)

Local Institution - 0075

Antalya, 07070, Turkey (Türkiye)

Local Institution - 0074

Istanbul, 34300, Turkey (Türkiye)

Local Institution - 0006

Withington, Manchester M20 4BX, United Kingdom

Local Institution - 0005

London, NW1 2BU, United Kingdom