NCT04109066
Active, not recruiting
September 30, 2019
July 22, 2022
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.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET Nivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice |
Biological: nivolumab Specified Dose on Specified days Drug: paclitaxel (PTX) Specified dose on Specified days Drug: anthracycline Specified dose on Specified days Drug: cyclophosphamide Specified dose on Specified days Drug: Endocrine Therapy Variable endocrine therapy of investigators choice Procedure: Surgery Surgery for breast cancer |
Placebo Comparator: Arm B: Placebo combined with neoadjuvant CT and adjuvant ET Nivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab placebo with adjuvant (post-surgery) endocrine therapy of investigator's choice |
Drug: paclitaxel (PTX) Specified dose on Specified days Other: nivolumab placebo Specified dose on Specified days Drug: anthracycline Specified dose on Specified days Drug: cyclophosphamide Specified dose on Specified days Drug: Endocrine Therapy Variable endocrine therapy of investigators choice Procedure: Surgery Surgery for breast cancer |
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
United States, Alabama
Local Institution - 0136
Mobile
United States, California
Local Institution - 0052
Greenbrae
United States, California
Local Institution - 0051
Whittier
United States, Connecticut
Local Institution - 0182
Stamford
United States, Florida
Local Institution - 0150
Jacksonville
United States, Florida
Local Institution - 0097
Miami
United States, Florida
Local Institution - 0149
Pensacola
United States, Florida
Local Institution - 0120
Tallahassee
United States, Georgia
Local Institution - 0054
Athens
United States, Georgia
Local Institution - 0107
Atlanta
United States, Georgia
Local Institution - 0056
Columbus
United States, Illinois
Local Institution - 0221
Chicago
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne
United States, Kentucky
Local Institution
Louisville
United States, Maine
New England Cancer Specialists
Topsham
United States, Maryland
American Oncology Partners of Maryland, PA
Bethesda
United States, Missouri
HCA Midwest Division
Kansas City
United States, New Jersey
Local Institution - 0109
Florham Park
United States, New Jersey
Local Institution - 0050
Hackensack
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
United States, New Mexico
Local Institution - 0181
Albuquerque
United States, New York
Local Institution - 0041
Bronx
United States, North Carolina
Local Institution - 0283
Charlotte
United States, North Carolina
Duke Cancer Institute
Durham
United States, North Carolina
Local Institution
Winston-Salem
United States, Ohio
Local Institution - 0053
Cleveland
United States, Tennessee
Local Institution - 0218
Chattanooga
United States, Texas
Local Institution - 0121
Fort Worth
United States, Virginia
Local Institution - 0224
Fairfax
United States, Virginia
Local Institution - 0122
Fredericksburg
United States, Virginia
Virginia Cancer Institute
Richmond
United States, Washington
Local Institution - 0274
Seattle
Argentina, Buenos Aires
Local Institution - 0020
Caba
Argentina, Buenos Aires
Local Institution
Ciudad Autonoma Beunos Aires
Argentina, Buenos Aires
Local Institution - 0015
La Plata
Argentina, Cordoba
Local Institution - 0303
Río Cuarto
Argentina, Distrito Federal
Local Institution
Buenos Aires
Argentina, Distrito Federal
Local Institution - 0008
Capital Federal
Argentina, Distrito Federal
Local Institution - 0013
Ciudad Autonoma de Buenos Aires
Argentina, Santa FE
Local Institution
Rosario
Argentina
Clinica Adventista Belgrano
Buenos Aires
Argentina
Local Institution - 0021
Cordoba
Argentina
Local Institution
Cordoba
Argentina
Local Institution
La Rioja
Argentina
Local Institution
Viedma
Australia, New South Wales
Local Institution
Darlinghurst
Australia, New South Wales
Local Institution - 0071
North Sydney
Australia, New South Wales
Port Macquarie Base Hospital
Port Macquarie
Australia, New South Wales
Local Institution
Sydney
Australia, Queensland
Royal Brisbane and Womens Hospital
Herston
Australia, South Australia
Calvary Central Districts Hospital
Elizabeth Vale
Australia, Victoria
Monash Medical Centre Clayton
Clayton
Australia, Victoria
Local Institution
Franskton
Australia, Victoria
Austin Hospital
Heidelberg
Australia, Victoria
Local Institution - 0070
Melbourne
Australia, Victoria
Local Institution - 0068
North Ballarat
Australia, Western Australia
Local Institution
Perth
Austria
Local Institution - 0045
Graz
Austria
Local Institution - 0042
Innsbruck
Austria
Local Institution - 0048
Salzburg
Austria
Local Institution - 0046
Wien
Austria
Local Institution - 0047
Wien
Belgium
Local Institution - 0187
Brussels
Belgium
Local Institution - 0030
Charleroi
Belgium
Local Institution - 0037
Edegem
Belgium
Local Institution - 0032
Gent
Belgium
Local Institution - 0031
Liege
Brazil, Ceara
Local Institution - 0130
Fortaleza
Brazil, Distrito Federal
Local Institution - 0225
Brasilia
Brazil, Goias
Local Institution - 0287
Goiânia
Brazil, Minas Gerais
Local Institution - 0133
Belo Horizonte
Brazil, RIO Grande DO SUL
Local Institution - 0132
Ijui
Brazil, RIO Grande DO SUL
Local Institution - 0288
Porto Alegre
Brazil, Rio Grande Do Sul
Local Institution - 0131
Porto Alegre
Brazil, RIO Grande DO SUL
Local Institution - 0135
Porto Alegre
Brazil, RIO Grande DO SUL
Local Institution - 0273
Santa Cruz do Sul
Brazil, SAO Paulo
Local Institution - 0134
Barretos
Brazil, SAO Paulo
Local Institution - 0128
Santo Andre
Brazil, SAO Paulo
Local Institution - 0272
São Paulo
Brazil
Local Institution - 0129
Rio de Janeiro
Brazil
Local Institution - 0144
São Paulo
Brazil
Local Institution - 0104
São Paulo
Canada, Nova Scotia
Local Institution
Halifax
Canada, Ontario
Local Institution
Oshawa
Canada, Ontario
Local Institution
Ottawa
Canada, Ontario
Local Institution
Thunder Bay
Canada, Ontario
Local Institution
Toronto
Canada, Ontario
Local Institution
Toronto
Canada, Quebec
Local Institution
Montreal
Canada, Quebec
Centre Hospitalier de l'Université de Montréal-Breast Cancer
Montréal
Canada, Quebec
Local Institution - 0058
Sherbrooke
Chile, Coquimbo
Local Institution - 0197
La Serena
Chile, Metropolitana
Local Institution - 0016
Santiago de Chile
Chile, Metropolitana
Local Institution - 0019
Santiago Region Metropolitana
Chile, Metropolitana
Local Institution - 0318
Santiago
Chile, Valparaiso
Local Institution - 0018
Vina del Mar
Chile
Local Institution - 0326
Antofagasta
China, Anhui
Local Institution - 0235
Bengbu
China, Anhui
Local Institution - 0239
Hefei
China, Beijing
Local Institution
Beijing
China, Beijing
Local Institution - 0215
Beijing
China, Chongqing
Local Institution - 0319
Chongqing
China, Chongqing
Local Institution - 0232
Chongqing
China, Guangdong
Local Institution - 0267
Guangzhou
China, Guangdong
Local Institution - 0241
Guangzhou
China, Guangdong
Local Institution
Guangzhou
China, Guizhou
Local Institution - 0312
Zunyi
China, Hebei
Local Institution - 0240
Shjiazhuang
China, Hebei
Local Institution - 0250
Wuhan
China, Heilongjiang
Local Institution - 0248
Harbin
China, Henan
Local Institution
Zhengzhou
China, Jilin
Local Institution - 0255
Changchun
China, Jilin
Local Institution - 0247
Changchun
China, Liaoning
Local Institution
Shenyang
China, Liaoning
Local Institution - 0252
Shenyang
China, Shan3xi
Local Institution - 0263
Xian
China, Shandong
Local Institution - 0245
Jinan
China, Shandong
Local Institution - 0256
Qingdao
China, Shandong
Local Institution - 0214
YanTai
China, Shanghai
Local Institution - 0127
Shanghai
China, Sichuan
Local Institution - 0244
Chengdu
China, Tianjin
Local Institution - 0254
Tianjin
China, Xinjiang
Local Institution - 0311
Urumqi
China, Zhejiang
Local Institution - 0238
Hangzhou
China, Zhejiang
Local Institution - 0231
Hangzhou
China, Zhejiang
Local Institution - 0237
Hangzhou
China
Local Institution
Xiamen
Colombia, Bogota
Local Institution
Colombia
Colombia, Distrito Capital De Bogotá
Local Institution - 0094
Bogotá
Colombia, Santander
Local Institution - 0098
Piedecuesta
Colombia
Local Institution - 0261
Barranquilla
Colombia
Local Institution - 0093
Cali
Colombia
Local Institution - 0113
Monteria
Colombia
Local Institution
Pereira
Colombia
Local Institution
Rionegro, Antioquia
Czechia
Klinika onkologie a radioterapie
Hradec Kralove
Czechia
Komplexni onkologicke centrum
Novy Jicin
Czechia
Onkologicka klinika
Olomouc
Czechia
Local Institution - 0099
Praha 10
Denmark
Local Institution - 0167
Aarhus N
Denmark
Local Institution - 0165
Herlev
Denmark
Local Institution - 0164
Kobenhavn O
Denmark
Local Institution - 0166
Naestved
Finland
Local Institution - 0001
Helsinki
Finland
Local Institution - 0160
Tampere
France
Local Institution - 0004
Besancon
France
Local Institution - 0024
Brest
France
Centre Jean Perrin
Clermont-ferrand
France
Clinique Victor Hugo
Le Mans
France
Hopital Prive Jean Mermoz
Lyon
France
Local Institution - 0152
Montpellier
France
Hopital Europeen Georges Pompidou
Paris
France
Local Institution - 0195
Plerin
France
Institut De Cancerologie De L Ouest
Saint Herblain Cedex
France
Clinique Sainte Anne
Strasbourg
France
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon
France
Local Institution - 0003
Villejuif
Germany, Bayern
Local Institution - 0084
München
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 - 0079
Saarbruecken
Germany
Local Institution - 0157
Velbert
Germany
Local Institution - 0105
Würzburg
Hong Kong
Local Institution - 0115
Hong Kong
Ireland, Dublin
Local Institution - 0034
Dublin 8
Ireland
Cork University Hospital
Cork
Ireland
Local Institution
Dublin
Italy
Local Institution
Catania
Italy
Azienda Ospedaliero-Universitaria Mater Domini
Catanzaro
Italy
Local Institution - 0207
Milano
Italy
Local Institution - 0124
Napoli
Italy
Local Institution - 0183
Napoli
Italy
Local Institution - 0155
Padova
Italy
Local Institution - 0126
Pavia
Italy
Local Institution
Roma
Italy
Local Institution - 0125
Rozzano (MI)
Korea, Republic of
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
Mexico, BAJA California
Local Institution - 0262
Tijuana
Mexico, Distrito Federal
Local Institution - 0168
Mexico City
Mexico, Distrito Federal
Local Institution - 0154
Mexico City
Mexico, Jalisco
Local Institution
Zapopan
Mexico, Nuevo LEON
Local Institution - 0137
Monterrey
Mexico, Yucatán
Local Institution - 0212
Merida
Mexico
Local Institution
Campeche
Mexico
Local Institution - 0091
Chihuahua
Mexico
Local Institution
Colima
Mexico
Local Institution - 0141
Oaxaca
Netherlands
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam
Netherlands
Local Institution - 0177
Breda
Netherlands
Local Institution - 0199
Deventer
Netherlands
Local Institution
Rotterdam
Netherlands
Local Institution
Utrecht
Poland
Local Institution - 0335
Bydgoszcz
Poland
Local Institution - 0334
Gliwice
Poland
Oddzial Dzienny Chemioterapii
Koszalin
Poland
Local Institution
Krakow
Poland
Klinika Onkologii CZMP
Lodz
Poland
Local Institution
Opole
Poland
Local Institution - 0060
Warszawa
Portugal
Local Institution - 0210
Lisboa
Portugal
Local Institution - 0211
Lisboa
Portugal
Local Institution - 0209
Porto
Puerto Rico
Local Institution - 0110
Ponce
Romania
Local Institution - 0029
Bucharest
Romania
Local Institution
Bucharest
Romania
Local Institution - 0025
Bucuresti
Romania
Local Institution
Craiova
Romania
Local Institution - 0027
Floresti
Romania
Local Institution
Suceava
Russian Federation
Local Institution
Krasnodar
Russian Federation
Local Institution
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
Singapore
Local Institution - 0078
Singapore
Singapore
Local Institution - 0076
Singapore
Singapore
Local Institution - 0077
Singapore
Spain
Local Institution - 0171
Barcelona
Spain
Local Institution - 0172
Barcelona
Spain
Local Institution - 0205
Elche (Alicante)
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
Switzerland
Local Institution - 0184
Basel
Switzerland
CHUV
Lausanne
Switzerland
Local Institution - 0185
Thun
Taiwan
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
Turkey
Local Institution - 0073
Adana
Turkey
Local Institution
Ankara
Turkey
Local Institution
Antalya
Turkey
Local Institution
Istanbul
United Kingdom, Manchester
Local Institution - 0006
Withington
United Kingdom
Local Institution - 0005
London
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb