Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

521

Study ID:

NCT04109066

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 235 Locations for this study

See Locations Near You

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
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne Indiana, 46804, United States
Local Institution
Louisville Kentucky, 40202, United States
New England Cancer Specialists
Topsham Maine, 04086, United States
American Oncology Partners of Maryland, PA
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
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Local Institution - 0181
Albuquerque New Mexico, 87131, United States
Local Institution - 0041
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
Winston-Salem North Carolina, 27103, United States
Local Institution - 0053
Cleveland Ohio, 44109, United States
Local Institution - 0218
Chattanooga Tennessee, 37404, 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
Ciudad Autonoma Beunos Aires Buenos Aires, 1431, Argentina
Local Institution - 0015
La Plata Buenos Aires, 1900, Argentina
Local Institution - 0303
Río Cuarto Cordoba, 5800, Argentina
Local Institution
Buenos Aires Distrito Federal, C1199, Argentina
Local Institution - 0008
Capital Federal Distrito Federal, C1280, Argentina
Local Institution - 0013
Ciudad Autonoma de Buenos Aires Distrito Federal, 0, Argentina
Local Institution
Rosario Santa FE, 2000, Argentina
Clinica Adventista Belgrano
Buenos Aires , 1430, Argentina
Local Institution - 0020
Buenos Aires , C1417, Argentina
Local Institution
Cordoba , 5004, Argentina
Local Institution - 0021
Cordoba , X5000, Argentina
Local Institution
La Rioja , , Argentina
Local Institution
Viedma , , Argentina
Local Institution
Darlinghurst New South Wales, 2010, Australia
Local Institution - 0071
North Sydney New South Wales, 2060, Australia
Port Macquarie Base Hospital
Port Macquarie New South Wales, 2444, Australia
Local Institution
Sydney New South Wales, 2145, Australia
Royal Brisbane and Womens Hospital
Herston Queensland, 4029, Australia
Calvary Central Districts Hospital
Elizabeth Vale South Australia, 5112, Australia
Local Institution - 0066
Clayton Victoria, 3168, Australia
Local Institution
Franskton Victoria, 3199, Australia
Austin Hospital
Heidelberg Victoria, 3084, Australia
Local Institution - 0070
Melbourne Victoria, 3000, Australia
Local Institution - 0068
North Ballarat Victoria, 33500, Australia
Local Institution
Perth Western Australia, 6008, Australia
Local Institution - 0045
Graz , 8036, Austria
Local Institution - 0042
Innsbruck , 6020, Austria
Local Institution - 0048
Salzburg , 5020, Austria
Local Institution - 0046
Wien , 1090, Austria
Local Institution - 0047
Wien , 1090, Austria
Local Institution - 0187
Brussels , 1090, Belgium
Local Institution - 0030
Charleroi , 6000, Belgium
Local Institution - 0037
Edegem , 2650, Belgium
Local Institution - 0032
Gent , 9000, Belgium
Local Institution - 0031
Liege , 4000, Belgium
Local Institution - 0130
Fortaleza Ceara, 60135, Brazil
Local Institution - 0225
Brasilia Distrito Federal, 70200, Brazil
Local Institution - 0287
Goiânia Goias, 74605, Brazil
Local Institution - 0133
Belo Horizonte Minas Gerais, 30130, Brazil
Local Institution - 0132
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0288
Porto Alegre RIO Grande DO SUL, 90035, Brazil
Local Institution - 0131
Porto Alegre Rio Grande Do Sul, 90050, Brazil
Local Institution - 0135
Porto Alegre RIO Grande DO SUL, 90610, Brazil
Local Institution - 0273
Santa Cruz do Sul RIO Grande DO SUL, 96830, Brazil
Local Institution - 0134
Barretos SAO Paulo, 14784, Brazil
Local Institution - 0128
Santo Andre SAO Paulo, 09080, Brazil
Local Institution - 0272
São Paulo SAO Paulo, 01229, Brazil
Local Institution - 0129
Rio de Janeiro , 22793, Brazil
Local Institution - 0144
São Paulo , 01317, Brazil
Local Institution - 0104
São Paulo , 04378, Brazil
Local Institution
Halifax Nova Scotia, B3H 2, Canada
Local Institution
Oshawa Ontario, L1G 2, Canada
Local Institution
Ottawa Ontario, K1H 8, Canada
Local Institution
Thunder Bay Ontario, P7B 6, Canada
Local Institution
Toronto Ontario, M3M 0, Canada
Local Institution
Toronto Ontario, M5G 2, Canada
Local Institution
Montreal Quebec, H3T 1, Canada
Centre Hospitalier de l'Université de Montréal-Breast Cancer
Montréal Quebec, H2X 0, Canada
Local Institution - 0058
Sherbrooke Quebec, J1H 5, Canada
Local Institution - 0197
La Serena Coquimbo, 17204, Chile
Local Institution - 0016
Santiago de Chile Metropolitana, 0, Chile
Local Institution - 0019
Santiago Region Metropolitana Metropolitana, 83300, Chile
Local Institution - 0318
Santiago Metropolitana, 69009, Chile
Local Institution - 0018
Vina del Mar Valparaiso, 25205, Chile
Local Institution - 0326
Antofagasta , , Chile
Local Institution - 0235
Bengbu Anhui, 23300, China
Local Institution - 0239
Hefei Anhui, 23003, China
Local Institution
Beijing Beijing, 10002, China
Local Institution - 0215
Beijing Beijing, 10004, China
Local Institution - 0319
Chongqing Chongqing, 40001, China
Local Institution - 0232
Chongqing Chongqing, 40003, China
Local Institution - 0267
Guangzhou Guangdong, 51006, China
Local Institution - 0241
Guangzhou Guangdong, 51008, China
Local Institution
Guangzhou Guangdong, 51051, China
Local Institution - 0312
Zunyi Guizhou, 56300, China
Local Institution - 0240
Shjiazhuang Hebei, 50051, China
Local Institution - 0250
Wuhan Hebei, 43002, China
Local Institution - 0248
Harbin Heilongjiang, 15000, China
Local Institution
Zhengzhou Henan, , China
Local Institution - 0255
Changchun Jilin, 13001, China
Local Institution - 0247
Changchun Jilin, 13002, China
Local Institution
Shenyang Liaoning, 11000, China
Local Institution - 0252
Shenyang Liaoning, 11004, China
Local Institution - 0263
Xian Shan3xi, 71006, China
Local Institution - 0245
Jinan Shandong, 25011, China
Local Institution - 0256
Qingdao Shandong, 26600, China
Local Institution - 0214
YanTai Shandong, 26400, China
Local Institution - 0127
Shanghai Shanghai, 20003, China
Local Institution - 0244
Chengdu Sichuan, 61004, China
Local Institution - 0254
Tianjin Tianjin, 30006, China
Local Institution - 0311
Urumqi Xinjiang, 83000, China
Local Institution - 0238
Hangzhou Zhejiang, 31000, China
Local Institution - 0231
Hangzhou Zhejiang, 31000, China
Local Institution - 0237
Hangzhou Zhejiang, 31000, China
Local Institution
Xiamen , , China
Local Institution
Colombia Bogota, , Colombia
Local Institution - 0094
Bogotá Distrito Capital De Bogotá, 11022, Colombia
Local Institution - 0098
Piedecuesta Santander, 68101, Colombia
Local Institution - 0261
Barranquilla , 08002, Colombia
Local Institution - 0093
Cali , 0, Colombia
Local Institution - 0113
Monteria , 23000, Colombia
Local Institution
Pereira , , Colombia
Local Institution
Rionegro, Antioquia , , Colombia
Klinika onkologie a radioterapie
Hradec Kralove , 500 0, Czechia
Komplexni onkologicke centrum
Novy Jicin , 741 0, Czechia
Onkologicka klinika
Olomouc , 77900, Czechia
Local Institution - 0099
Praha 10 , 100 3, Czechia
Local Institution - 0167
Aarhus N , 8200, Denmark
Local Institution - 0165
Herlev , 2730, Denmark
Local Institution - 0164
Kobenhavn O , 2100, Denmark
Local Institution - 0166
Naestved , 4700, Denmark
Local Institution - 0001
Helsinki , 00029, Finland
Local Institution - 0160
Tampere , 33521, Finland
Local Institution - 0004
Besancon , 25030, France
Local Institution - 0024
Brest , 29200, France
Centre Jean Perrin
Clermont-ferrand , 63000, France
Clinique Victor Hugo
Le Mans , 72000, France
Hopital Prive Jean Mermoz
Lyon , 69000, France
Local Institution - 0152
Montpellier , 34298, France
Hopital Europeen Georges Pompidou
Paris , 75015, France
Local Institution - 0195
Plerin , 22190, France
Institut De Cancerologie De L Ouest
Saint Herblain Cedex , 44805, France
Clinique Sainte Anne
Strasbourg , 67085, France
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon , 83100, France
Local Institution - 0003
Villejuif , 94800, France
Local Institution - 0084
München Bayern, 80337, Germany
Local Institution - 0083
Berlin , 13125, 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 - 0080
Köln , 50937, Germany
Local Institution - 0196
Leipzig , 04103, Germany
Local Institution - 0111
Moenchengladbach , 41061, Germany
Local Institution - 0156
Rostock , 18059, Germany
Local Institution - 0079
Saarbruecken , 66112, 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 8 Dublin, , Ireland
Cork University Hospital
Cork , , Ireland
Local Institution
Dublin , 9, Ireland
Local Institution
Catania , 95122, Italy
Azienda Ospedaliero-Universitaria Mater Domini
Catanzaro , 88100, Italy
Local Institution - 0207
Milano , 20141, Italy
Local Institution - 0124
Napoli , 80131, Italy
Local Institution - 0183
Napoli , 80131, Italy
Istituto Oncologico Veneto IOV
Padova , 35128, Italy
Local Institution - 0126
Pavia , 27100, Italy
Local Institution
Roma , 00128, Italy
Local Institution - 0125
Rozzano (MI) , 20089, Italy
Local Institution - 0325
Seongnam , 13620, Korea, Republic of
Local Institution - 0295
Seoul , 03080, Korea, Republic of
Local Institution - 0320
Seoul , 03722, Korea, Republic of
Local Institution - 0290
Seoul , 05505, Korea, Republic of
Local Institution - 0291
Seoul , 06351, Korea, Republic of
Local Institution - 0262
Tijuana BAJA California, 22010, Mexico
Local Institution - 0168
Mexico City Distrito Federal, 03100, Mexico
Local Institution - 0154
Mexico City Distrito Federal, 14080, Mexico
Local Institution
Zapopan Jalisco, 45070, Mexico
Local Institution - 0137
Monterrey Nuevo LEON, 64320, Mexico
Local Institution - 0212
Merida Yucatán, 97125, Mexico
Local Institution
Campeche , 24050, Mexico
Local Institution - 0091
Chihuahua , 31000, Mexico
Local Institution
Colima , 28018, Mexico
Local Institution - 0141
Oaxaca , 68020, Mexico
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , 1066 , Netherlands
Local Institution - 0177
Breda , 4818C, Netherlands
Local Institution - 0199
Deventer , 7416 , Netherlands
Local Institution
Rotterdam , 3000 , Netherlands
Local Institution
Utrecht , 3584 , Netherlands
Local Institution - 0335
Bydgoszcz , 85796, Poland
Local Institution - 0334
Gliwice , 44-10, Poland
Oddzial Dzienny Chemioterapii
Koszalin , 75-58, Poland
Local Institution
Krakow , 31-53, Poland
Local Institution - 0063
Lodz , 93-33, Poland
Local Institution
Opole , 45-06, Poland
Local Institution - 0060
Warszawa , 02-78, Poland
Local Institution - 0210
Lisboa , 1500-, Portugal
Local Institution - 0211
Lisboa , 1649-, Portugal
Local Institution - 0209
Porto , 4200, Portugal
Local Institution - 0110
Ponce , 00716, Puerto Rico
Local Institution - 0029
Bucharest , 01117, Romania
Local Institution
Bucharest , 02232, Romania
Local Institution - 0025
Bucuresti , 02232, Romania
Local Institution
Craiova , 20034, Romania
Local Institution - 0027
Floresti , 40728, Romania
Local Institution - 0026
Suceava , 72023, Romania
Local Institution
Krasnodar , 35004, Russian Federation
Local Institution
Moscow , 11547, Russian Federation
Local Institution
Moscow , 12536, Russian Federation
Local Institution - 0285
Moskva , 11112, Russian Federation
Local Institution
Ryazan , 39001, Russian Federation
Local Institution - 0284
Saint Petersburg , 19775, Russian Federation
Local Institution - 0306
Sankt-Peterburg , 19410, Russian Federation
Local Institution
Sochi , 35405, Russian Federation
Local Institution - 0078
Singapore , 11922, Singapore
Local Institution - 0076
Singapore , 16961, Singapore
Local Institution - 0077
Singapore , 30844, Singapore
Local Institution - 0171
Barcelona , 08035, Spain
Local Institution - 0172
Barcelona , 08036, Spain
Local Institution - 0205
Elche (Alicante) , 03203, Spain
Local Institution - 0173
Madrid , 28040, Spain
Local Institution - 0176
Madrid , 28050, Spain
Local Institution - 0169
Malaga , 29010, Spain
Local Institution - 0204
Pamplona , 31008, Spain
Local Institution - 0174
Santiago de Compostela , 15706, Spain
Local Institution - 0170
Sevilla , 41013, Spain
Local Institution - 0184
Basel , 4031, Switzerland
CHUV
Lausanne , 1011, Switzerland
Local Institution - 0185
Thun , 3600, Switzerland
Local Institution - 0301
Kaohsiung , 807, Taiwan
Local Institution - 0300
Tainan City , 71004, Taiwan
Local Institution - 0298
Tainan , 70457, Taiwan
Local Institution - 0305
Taipei , 10449, Taiwan
Local Institution - 0297
Taipei , 112, Taiwan
Local Institution - 0073
Adana , 01060, Turkey
Local Institution
Ankara , 06520, Turkey
Local Institution
Antalya , 07070, Turkey
Local Institution
Istanbul , 34300, Turkey
Local Institution - 0006
Withington Manchester, M20 4, United Kingdom
Local Institution - 0005
London , NW1 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

521

Study ID:

NCT04109066

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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