Spots Global Cancer Trial Database for Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
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Trial Identification
Brief Title: Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Official Title: A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Study ID: NCT04109066
Conditions
Study Description
Brief Summary: A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution - 0136, Mobile, Alabama, United States
Local Institution - 0052, Greenbrae, California, United States
Local Institution - 0051, Whittier, California, United States
Local Institution - 0182, Stamford, Connecticut, United States
Local Institution - 0150, Jacksonville, Florida, United States
Local Institution - 0097, Miami, Florida, United States
Local Institution - 0149, Pensacola, Florida, United States
Local Institution - 0120, Tallahassee, Florida, United States
Local Institution - 0054, Athens, Georgia, United States
Local Institution - 0107, Atlanta, Georgia, United States
Local Institution - 0056, Columbus, Georgia, United States
Local Institution - 0221, Chicago, Illinois, United States
Local Institution - 0227, Fort Wayne, Indiana, United States
Local Institution - 0222, Topsham, Maine, United States
Local Institution - 0146, Bethesda, Maryland, United States
HCA Midwest Division, Kansas City, Missouri, United States
Local Institution - 0109, Florham Park, New Jersey, United States
Local Institution - 0050, Hackensack, New Jersey, United States
Local Institution - 0180, New Brunswick, New Jersey, United States
Local Institution - 0181, Albuquerque, New Mexico, United States
Local Institution - 0041, Bronx, New York, United States
Local Institution - 0283, Charlotte, North Carolina, United States
Duke Cancer Institute, Durham, North Carolina, United States
Local Institution - 0053, Cleveland, Ohio, United States
Local Institution - 0218, Nashville, Tennessee, United States
Local Institution - 0121, Fort Worth, Texas, United States
Local Institution - 0224, Fairfax, Virginia, United States
Local Institution - 0122, Fredericksburg, Virginia, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Local Institution - 0274, Seattle, Washington, United States
Local Institution - 0012, Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
Local Institution - 0015, La Plata, Buenos Aires, Argentina
Local Institution - 0020, Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0294, Córdoba, Cordoba, Argentina
Local Institution - 0303, Río Cuarto, Cordoba, Argentina
Local Institution - 0011, Caba, Distrito Federal, Argentina
Local Institution - 0008, Capital Federal, Distrito Federal, Argentina
Local Institution - 0013, Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina
Local Institution - 0014, Rosario Santa Fe, Santa FE, Argentina
Local Institution - 0021, Cordoba, , Argentina
Local Institution, La Rioja, , Argentina
Local Institution, Viedma, , Argentina
Local Institution - 0071, North Sydney, New South Wales, Australia
Local Institution - 0069, Port Macquarie, New South Wales, Australia
Local Institution - 0072, Herston, Queensland, Australia
Local Institution - 0067, Elizabeth Vale, South Australia, Australia
Local Institution - 0066, Clayton, Victoria, Australia
Local Institution - 0142, Clayton, Victoria, Australia
Local Institution - 0070, Melbourne, Victoria, Australia
Local Institution - 0068, North Ballarat, Victoria, Australia
Local Institution - 0045, Graz, , Austria
Local Institution - 0042, Innsbruck, , Austria
Local Institution - 0048, Salzburg, , Austria
Local Institution - 0046, Wien, , Austria
Local Institution - 0047, Wien, , Austria
Local Institution - 0187, Brussels, , Belgium
Local Institution - 0030, Charleroi, , Belgium
Local Institution - 0037, Edegem, , Belgium
Local Institution - 0032, Gent, , Belgium
Local Institution - 0031, Liege, , Belgium
Local Institution - 0130, Fortaleza, Ceara, Brazil
Local Institution - 0225, Brasilia, Distrito Federal, Brazil
Local Institution - 0287, Goiânia, Goias, Brazil
Local Institution - 0133, Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0132, Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0288, Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0131, Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0135, Porto Alegre, RIO Grande DO SUL, Brazil
Local Institution - 0273, Santa Cruz do Sul, Rio Grande Do Sul, Brazil
Local Institution - 0134, Barretos, SAO Paulo, Brazil
Local Institution - 0272, São Paulo, SAO Paulo, Brazil
Local Institution - 0128, Santo André, São Paulo, Brazil
Local Institution - 0129, Rio de Janeiro, , Brazil
Local Institution - 0144, São Paulo, , Brazil
Local Institution - 0104, São Paulo, , Brazil
Local Institution - 0194, Montreal, Quebec, Canada
Local Institution - 0095, Montréal, Quebec, Canada
Local Institution - 0058, Sherbrooke, Quebec, Canada
Local Institution - 0197, La Serena, Coquimbo, Chile
Local Institution - 0016, Santiago de Chile, Metropolitana, Chile
Local Institution - 0019, Santiago Region Metropolitana, Metropolitana, Chile
Local Institution - 0318, Santiago, Metropolitana, Chile
Local Institution - 0018, Vina del Mar, Valparaiso, Chile
Local Institution - 0326, Antofagasta, , Chile
Local Institution - 0235, Bengbu, Anhui, China
Local Institution - 0239, Hefei, Anhui, China
Local Institution, Beijing, Beijing, China
Local Institution - 0215, Beijing, Beijing, China
Local Institution - 0319, Chongqing, Chongqing, China
Local Institution - 0232, Chongqing, Chongqing, China
Local Institution - 0267, Guangzhou, Guangdong, China
Local Institution - 0241, Guangzhou, Guangdong, China
Local Institution, Guangzhou, Guangdong, China
Local Institution - 0312, Zunyi, Guizhou, China
Local Institution - 0240, Shjiazhuang, Hebei, China
Local Institution - 0250, Wuhan, Hebei, China
Local Institution - 0248, Harbin, Heilongjiang, China
Local Institution, Zhengzhou, Henan, China
Local Institution - 0255, Changchun, Jilin, China
Local Institution - 0247, Changchun, Jilin, China
Local Institution - 0252, Shenyang, Liaoning, China
Local Institution - 0263, Xian, Shan3xi, China
Local Institution - 0245, Jinan, Shandong, China
Local Institution - 0256, Qingdao, Shandong, China
Local Institution - 0214, YanTai, Shandong, China
Local Institution - 0127, Shanghai, Shanghai, China
Local Institution - 0244, Chengdu, Sichuan, China
Local Institution - 0254, Tianjin, Tianjin, China
Local Institution - 0311, Urumqi, Xinjiang, China
Local Institution - 0238, Hangzhou, Zhejiang, China
Local Institution - 0231, Hangzhou, Zhejiang, China
Local Institution - 0237, Hangzhou, Zhejiang, China
Local Institution - 0261, Barranquilla, Atlántico, Colombia
Local Institution - 0203, Colombia, Bogota, Colombia
Local Institution - 0113, Montería, Córdoba, Colombia
Local Institution - 0094, Bogotá, Distrito Capital De Bogotá, Colombia
Local Institution - 0098, Piedecuesta, Santander, Colombia
Local Institution - 0093, Cali, , Colombia
Local Institution - 0271, Pereira, , Colombia
Local Institution - 0202, Rionegro, , Colombia
Local Institution - 0100, Hradec Kralove, , Czechia
Local Institution - 0103, Novy Jicin, , Czechia
Local Institution - 0101, Olomouc, , Czechia
Local Institution - 0099, Praha 10, , Czechia
Local Institution - 0167, Aarhus N, , Denmark
Local Institution - 0165, Herlev, , Denmark
Local Institution - 0164, Kobenhavn O, , Denmark
Local Institution - 0166, Naestved, , Denmark
Local Institution - 0001, Helsinki, , Finland
Local Institution - 0160, Tampere, , Finland
Local Institution - 0216, Le Mans, Sarthe, France
Local Institution - 0004, Besancon, , France
Local Institution - 0024, Brest, , France
Local Institution - 0162, Clermont-Ferrand, , France
Local Institution - 0153, Lyon, , France
Local Institution - 0152, Montpellier, , France
Local Institution - 0161, Paris, , France
Local Institution - 0195, Plerin, , France
Local Institution - 0002, Saint Herblain, , France
Local Institution - 0258, Strasbourg, , France
Local Institution - 0228, Toulon Cedex, , France
Local Institution - 0003, Villejuif, , France
Local Institution - 0084, München, Bayern, Germany
Local Institution - 0079, Saarbruecken, Saarland, Germany
Local Institution - 0083, Berlin, , Germany
Local Institution - 0112, Dresden, , Germany
Local Institution - 0081, Essen, , Germany
Local Institution - 0158, Frankfurt, , Germany
Local Institution - 0223, Hamburg, , Germany
Local Institution - 0087, Heidelberg, , Germany
Local Institution - 0089, Homburg, , Germany
Local Institution - 0080, Köln, , Germany
Local Institution - 0196, Leipzig, , Germany
Local Institution - 0111, Moenchengladbach, , Germany
Local Institution - 0156, Rostock, , Germany
Local Institution - 0157, Velbert, , Germany
Local Institution - 0105, Würzburg, , Germany
Local Institution - 0115, Hong Kong, , Hong Kong
Local Institution - 0034, Dublin 8, Dublin, Ireland
Local Institution - 0035, Beaumont, , Ireland
Local Institution - 0036, Cork, , Ireland
Local Institution - 0191, Catanzaro, , Italy
Local Institution - 0207, Milano, , Italy
Azienda Ospedaliero Universitaria Federico II di Napoli, Napoli, , Italy
Istituto Nazionale Tumori Fondazione Pascale, Napoli, , Italy
Istituto Oncologico Veneto IOV, Padova, , Italy
Fondazione Irccs - Policlinico San Matteo, Pavia, , Italy
Policlinico Universitario Campus Biomedico Di Roma, Roma, , Italy
Local Institution - 0125, Rozzano (MI), , Italy
Local Institution - 0325, Seongnam, , Korea, Republic of
Local Institution - 0295, Seoul, , Korea, Republic of
Local Institution - 0320, Seoul, , Korea, Republic of
Local Institution - 0290, Seoul, , Korea, Republic of
Local Institution - 0291, Seoul, , Korea, Republic of
Local Institution - 0262, Tijuana, BAJA California, Mexico
Local Institution - 0168, Mexico City, Distrito Federal, Mexico
Local Institution - 0154, Mexico City, Distrito Federal, Mexico
Local Institution - 0330, Zapopan, Jalisco, Mexico
Local Institution - 0137, Monterrey, Nuevo LEON, Mexico
Local Institution - 0212, Merida, Yucatán, Mexico
Local Institution - 0280, Campeche, , Mexico
Local Institution - 0091, Chihuahua, , Mexico
Local Institution - 0145, Colima, , Mexico
Local Institution - 0141, Oaxaca, , Mexico
Local Institution - 0033, Amsterdam, , Netherlands
Local Institution - 0177, Breda, , Netherlands
Local Institution - 0199, Deventer, , Netherlands
Local Institution - 0147, Utrecht, , Netherlands
Local Institution - 0335, Bydgoszcz, , Poland
Local Institution - 0061, Koszalin, , Poland
Local Institution - 0059, Krakow, , Poland
Local Institution - 0063, Lodz, , Poland
Local Institution - 0062, Opole, , Poland
Local Institution - 0060, Warszawa, , Poland
Local Institution - 0334, Gliwice, Śląskie, Poland
Local Institution - 0210, Lisboa, , Portugal
Local Institution - 0211, Lisboa, , Portugal
Local Institution - 0209, Porto, , Portugal
Local Institution - 0110, Ponce, , Puerto Rico
Local Institution - 0029, Bucharest, , Romania
Local Institution - 0270, Bucharest, , Romania
Local Institution - 0025, Bucuresti, , Romania
Local Institution - 0028, Craiova, , Romania
Local Institution - 0027, Floresti, , Romania
Local Institution - 0026, Suceava, , Romania
Local Institution, Krasnodar, , Russian Federation
Local Institution - 0119, Moscow, , Russian Federation
Local Institution, Moscow, , Russian Federation
Local Institution - 0285, Moskva, , Russian Federation
Local Institution, Ryazan, , Russian Federation
Local Institution - 0284, Saint Petersburg, , Russian Federation
Local Institution - 0306, Sankt-Peterburg, , Russian Federation
Local Institution, Sochi, , Russian Federation
Local Institution - 0078, Singapore, , Singapore
Local Institution - 0076, Singapore, , Singapore
Local Institution - 0077, Singapore, , Singapore
Local Institution - 0205, Elche, Alicante, Spain
Local Institution - 0171, Barcelona, , Spain
Local Institution - 0172, Barcelona, , Spain
Local Institution - 0173, Madrid, , Spain
Local Institution - 0176, Madrid, , Spain
Local Institution - 0169, Malaga, , Spain
Local Institution - 0204, Pamplona, , Spain
Local Institution - 0174, Santiago de Compostela, , Spain
Local Institution - 0170, Sevilla, , Spain
Local Institution - 0175, Valencia, , Spain
Local Institution - 0184, Basel, , Switzerland
Local Institution - 0186, Lausanne, , Switzerland
Local Institution - 0185, Thun, , Switzerland
Local Institution - 0301, Kaohsiung, , Taiwan
Local Institution - 0300, Tainan City, , Taiwan
Local Institution - 0298, Tainan, , Taiwan
Local Institution - 0305, Taipei, , Taiwan
Local Institution - 0297, Taipei, , Taiwan
Local Institution - 0073, Adana, , Turkey
Local Institution - 0257, Ankara, , Turkey
Local Institution - 0075, Antalya, , Turkey
Local Institution - 0074, Istanbul, , Turkey
Local Institution - 0006, Withington, Manchester, United Kingdom
Local Institution - 0005, London, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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