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 (CheckMate 7FL)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Biological: nivolumab; Drug: paclitaxel (PTX); Drug: anthracycline; Drug: cyclophosphamide; Drug: Endocrine Therapy; Procedure: Surgery; Other: nivolumab placebo

• Study Type: Interventional
• Enrollment (Actual): 521
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5000BAL
    • Local Institution - 0021
  • La Rioja, Argentina
    • Local Institution
  • Viedma, Argentina
    • Local Institution
  • Buenos Aires
    • Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
      • Local Institution - 0012
    • La Plata, Buenos Aires, Argentina, 1900
      • Local Institution - 0015
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1417DTB
      • Local Institution - 0020
  • Cordoba
    • Córdoba, Cordoba, Argentina, X5000FHP
      • Local Institution - 0294
    • Río Cuarto, Cordoba, Argentina, 5800
      • Local Institution - 0303
  • Distrito Federal
    • Caba, Distrito Federal, Argentina, 1430
      • Local Institution - 0011
    • Capital Federal, Distrito Federal, Argentina, C1280AEB
      • Local Institution - 0008
    • Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina
      • Local Institution - 0013
  • Santa FE
    • Rosario Santa Fe, Santa FE, Argentina, S2002KDS
      • Local Institution - 0014
• Australia
  • New South Wales
    • North Sydney, New South Wales, Australia, 2060
      • Local Institution - 0071
    • Port Macquarie, New South Wales, Australia, 2444
      • Local Institution - 0069
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Local Institution - 0072
  • South Australia
    • Elizabeth Vale, South Australia, Australia, 5112
      • Local Institution - 0067
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Local Institution - 0066
    • Clayton, Victoria, Australia, 3168
      • Local Institution - 0142
    • Melbourne, Victoria, Australia, 3000
      • Local Institution - 0070
    • North Ballarat, Victoria, Australia, 33500
      • Local Institution - 0068
• Austria
  • Graz, Austria, 8036
    • Local Institution - 0045
  • Innsbruck, Austria, 6020
    • Local Institution - 0042
  • Salzburg, Austria, 5020
    • Local Institution - 0048
  • Wien, Austria, 1090
    • Local Institution - 0046
  • Wien, Austria, 1090
    • Local Institution - 0047
• Belgium
  • Brussels, Belgium, 1090
    • Local Institution - 0187
  • Charleroi, Belgium, 6000
    • Local Institution - 0030
  • Edegem, Belgium, 2650
    • Local Institution - 0037
  • Gent, Belgium, 9000
    • Local Institution - 0032
  • Liege, Belgium, 4000
    • Local Institution - 0031
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Local Institution - 0129
  • São Paulo, Brazil, 01317-000
    • Local Institution - 0144
  • São Paulo, Brazil, 04378-500
    • Local Institution - 0104
  • Ceara
    • Fortaleza, Ceara, Brazil, 60135-237
      • Local Institution - 0130
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 70200-730
      • Local Institution - 0225
  • Goias
    • Goiânia, Goias, Brazil, 74605070
      • Local Institution - 0287
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Local Institution - 0133
  • RIO Grande DO SUL
    • Ijui, RIO Grande DO SUL, Brazil, 98700-000
      • Local Institution - 0132
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-001
      • Local Institution - 0288
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
      • Local Institution - 0135
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
      • Local Institution - 0131
    • Santa Cruz do Sul, Rio Grande Do Sul, Brazil, 96830-180
      • Local Institution - 0273
  • SAO Paulo
    • Barretos, SAO Paulo, Brazil, 14784-400
      • Local Institution - 0134
    • São Paulo, SAO Paulo, Brazil, 01229-010
      • Local Institution - 0272
  • São Paulo
    • Santo André, São Paulo, Brazil, 09060-870
      • Local Institution - 0128
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Local Institution - 0194
    • Montréal, Quebec, Canada, H2X 0C1
      • Local Institution - 0095
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Local Institution - 0058
• Chile
  • Antofagasta, Chile
    • Local Institution - 0326
  • Coquimbo
    • La Serena, Coquimbo, Chile, 1720430
      • Local Institution - 0197
  • Metropolitana
    • Santiago, Metropolitana, Chile, 6900941
      • Local Institution - 0318
    • Santiago Region Metropolitana, Metropolitana, Chile, 8330034
      • Local Institution - 0019
    • Santiago de Chile, Metropolitana, Chile
      • Local Institution - 0016
  • Valparaiso
    • Vina del Mar, Valparaiso, Chile, 2520598
      • Local Institution - 0018
• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Local Institution - 0235
    • Hefei, Anhui, China, 230031
      • Local Institution - 0239
  • Beijing
    • Beijing, Beijing, China, 100021
      • Local Institution
    • Beijing, Beijing, China, 100044
      • Local Institution - 0215
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Local Institution - 0319
    • Chongqing, Chongqing, China, 400030
      • Local Institution - 0232
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Local Institution
    • Guangzhou, Guangdong, China, 510060
      • Local Institution - 0267
    • Guangzhou, Guangdong, China, 510080
      • Local Institution - 0241
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Local Institution - 0312
  • Hebei
    • Shjiazhuang, Hebei, China, 50051
      • Local Institution - 0240
    • Wuhan, Hebei, China, 430022
      • Local Institution - 0250
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Local Institution - 0248
  • Henan
    • Zhengzhou, Henan, China
      • Local Institution
  • Jilin
    • Changchun, Jilin, China, 130012
      • Local Institution - 0255
    • Changchun, Jilin, China, 130021
      • Local Institution - 0247
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Local Institution - 0252
  • Shan3xi
    • Xian, Shan3xi, China, 710061
      • Local Institution - 0263
  • Shandong
    • Jinan, Shandong, China, 250117
      • Local Institution - 0245
    • Qingdao, Shandong, China, 266000
      • Local Institution - 0256
    • YanTai, Shandong, China, 264000
      • Local Institution - 0214
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Local Institution - 0127
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution - 0244
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Local Institution - 0254
  • Xinjiang
    • Urumqi, Xinjiang, China, 830000
      • Local Institution - 0311
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Local Institution - 0238
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution - 0231
    • Hangzhou, Zhejiang, China, 310009
      • Local Institution - 0237
• Colombia
  • Cali, Colombia
    • Local Institution - 0093
  • Pereira, Colombia, 660004
    • Local Institution - 0271
  • Rionegro, Colombia, 054047
    • Local Institution - 0202
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080020
      • Local Institution - 0261
  • Bogota
    • Colombia, Bogota, Colombia
      • Local Institution - 0203
  • Córdoba
    • Montería, Córdoba, Colombia, 230002
      • Local Institution - 0113
  • Distrito Capital De Bogotá
    • Bogotá, Distrito Capital De Bogotá, Colombia, 110221
      • Local Institution - 0094
  • Santander
    • Piedecuesta, Santander, Colombia, 681017
      • Local Institution - 0098
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Local Institution - 0100
  • Novy Jicin, Czechia, 741 01
    • Local Institution - 0103
  • Olomouc, Czechia, 779 00
    • Local Institution - 0101
  • Praha 10, Czechia, 100 34
    • Local Institution - 0099
• Denmark
  • Aarhus N, Denmark, 8200
    • Local Institution - 0167
  • Herlev, Denmark, 2730
    • Local Institution - 0165
  • Kobenhavn O, Denmark, 2100
    • Local Institution - 0164
  • Naestved, Denmark, 4700
    • Local Institution - 0166
• Finland
  • Helsinki, Finland, 00029
    • Local Institution - 0001
  • Tampere, Finland, 33521
    • Local Institution - 0160
• France
  • Besancon, France, 25030
    • Local Institution - 0004
  • Brest, France, 29200
    • Local Institution - 0024
  • Clermont-Ferrand, France, 63011
    • Local Institution - 0162
  • Lyon, France, 69000
    • Local Institution - 0153
  • Montpellier, France, 34298
    • Local Institution - 0152
  • Paris, France, 75908
    • Local Institution - 0161
  • Plerin, France, 22190
    • Local Institution - 0195
  • Saint Herblain, France, 44805
    • Local Institution - 0002
  • Strasbourg, France, 67085
    • Local Institution - 0258
  • Toulon Cedex, France, 83056
    • Local Institution - 0228
  • Villejuif, France, 94800
    • Local Institution - 0003
  • Sarthe
    • Le Mans, Sarthe, France, 72000
      • Local Institution - 0216
• Germany
  • Berlin, Germany, 13125
    • Local Institution - 0083
  • Dresden, Germany, 01307
    • Local Institution - 0112
  • Essen, Germany, 45147
    • Local Institution - 0081
  • Frankfurt, Germany, 60590
    • Local Institution - 0158
  • Hamburg, Germany, 20259
    • Local Institution - 0223
  • Heidelberg, Germany, 69126
    • Local Institution - 0087
  • Homburg, Germany, 66421
    • Local Institution - 0089
  • Köln, Germany, 50937
    • Local Institution - 0080
  • Leipzig, Germany, 04103
    • Local Institution - 0196
  • Moenchengladbach, Germany, 41061
    • Local Institution - 0111
  • Rostock, Germany, 18059
    • Local Institution - 0156
  • Velbert, Germany, 42551
    • Local Institution - 0157
  • Würzburg, Germany, 97080
    • Local Institution - 0105
  • Bayern
    • München, Bayern, Germany, 80337
      • Local Institution - 0084
  • Saarland
    • Saarbruecken, Saarland, Germany, 66113
      • Local Institution - 0079
• Hong Kong
  • Hong Kong, Hong Kong
    • Local Institution - 0115
• Ireland
  • Beaumont, Ireland, Dublin 9
    • Local Institution - 0035
  • Cork, Ireland
    • Local Institution - 0036
  • Dublin
    • Dublin 8, Dublin, Ireland
      • Local Institution - 0034
• Italy
  • Catanzaro, Italy, 88100
    • Local Institution - 0191
  • Milano, Italy, 20141
    • Local Institution - 0207
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori Fondazione Pascale
  • Napoli, Italy, 80131
    • Azienda Ospedaliero Universitaria Federico II di Napoli
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IOV
  • Pavia, Italy, 27100
    • Fondazione Irccs - Policlinico San Matteo
  • Roma, Italy, 00128
    • Policlinico Universitario Campus Biomedico Di Roma
  • Rozzano (MI), Italy, 20089
    • Local Institution - 0125
• Korea, Republic of
  • Seongnam, Korea, Republic of, 13620
    • Local Institution - 0325
  • Seoul, Korea, Republic of, 03080
    • Local Institution - 0295
  • Seoul, Korea, Republic of, 03722
    • Local Institution - 0320
  • Seoul, Korea, Republic of, 05505
    • Local Institution - 0290
  • Seoul, Korea, Republic of, 06351
    • Local Institution - 0291
• Mexico
  • Campeche, Mexico, 24050
    • Local Institution - 0280
  • Chihuahua, Mexico, 31000
    • Local Institution - 0091
  • Colima, Mexico, 28018
    • Local Institution - 0145
  • Oaxaca, Mexico, 68020
    • Local Institution - 0141
  • BAJA California
    • Tijuana, BAJA California, Mexico, 22010
      • Local Institution - 0262
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 03100
      • Local Institution - 0168
    • Mexico City, Distrito Federal, Mexico, 14080
      • Local Institution - 0154
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45070
      • Local Institution - 0330
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64320
      • Local Institution - 0137
  • Yucatán
    • Merida, Yucatán, Mexico, 97125
      • Local Institution - 0212
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Local Institution - 0033
  • Breda, Netherlands, 4818CK
    • Local Institution - 0177
  • Deventer, Netherlands, 7416 SE
    • Local Institution - 0199
  • Utrecht, Netherlands, 3584 CX
    • Local Institution - 0147
• Poland
  • Bydgoszcz, Poland, 85796
    • Local Institution - 0335
  • Koszalin, Poland, 75-581
    • Local Institution - 0061
  • Krakow, Poland, 30-688
    • Local Institution - 0059
  • Lodz, Poland, 93-338
    • Local Institution - 0063
  • Opole, Poland, 45-061
    • Local Institution - 0062
  • Warszawa, Poland, 02-781
    • Local Institution - 0060
  • Śląskie
    • Gliwice, Śląskie, Poland, 44-102
      • Local Institution - 0334
• Portugal
  • Lisboa, Portugal, 1500-650
    • Local Institution - 0210
  • Lisboa, Portugal, 1649-035
    • Local Institution - 0211
  • Porto, Portugal, 4200
    • Local Institution - 0209
• Puerto Rico
  • Ponce, Puerto Rico, 00716-0200
    • Local Institution - 0110
• Romania
  • Bucharest, Romania, 011171
    • Local Institution - 0029
  • Bucharest, Romania, 022328
    • Local Institution - 0270
  • Bucuresti, Romania, 022328
    • Local Institution - 0025
  • Craiova, Romania, 200542
    • Local Institution - 0028
  • Floresti, Romania, 407280
    • Local Institution - 0027
  • Suceava, Romania, 720237
    • Local Institution - 0026
• Russian Federation
  • Krasnodar, Russian Federation, 350040
    • Local Institution
  • Moscow, Russian Federation, 125367
    • Local Institution
  • Moscow, Russian Federation, 115478
    • Local Institution - 0119
  • Moskva, Russian Federation, 111123
    • Local Institution - 0285
  • Ryazan, Russian Federation, 390011
    • Local Institution
  • Saint Petersburg, Russian Federation, 197758
    • Local Institution - 0284
  • Sankt-Peterburg, Russian Federation, 194107
    • Local Institution - 0306
  • Sochi, Russian Federation, 354057
    • Local Institution
• Singapore
  • Singapore, Singapore, 119228
    • Local Institution - 0078
  • Singapore, Singapore, 308442
    • Local Institution - 0077
  • Singapore, Singapore, 168583
    • Local Institution - 0076
• Spain
  • Barcelona, Spain, 08035
    • Local Institution - 0171
  • Barcelona, Spain, 08036
    • Local Institution - 0172
  • Madrid, Spain, 28040
    • Local Institution - 0173
  • Madrid, Spain, 28050
    • Local Institution - 0176
  • Malaga, Spain, 29010
    • Local Institution - 0169
  • Pamplona, Spain, 31008
    • Local Institution - 0204
  • Santiago de Compostela, Spain, 15706
    • Local Institution - 0174
  • Sevilla, Spain, 41013
    • Local Institution - 0170
  • Valencia, Spain, 46010
    • Local Institution - 0175
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Local Institution - 0205
• Switzerland
  • Basel, Switzerland, 4031
    • Local Institution - 0184
  • Lausanne, Switzerland, 1011
    • Local Institution - 0186
  • Thun, Switzerland, 3600
    • Local Institution - 0185
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Local Institution - 0301
  • Tainan, Taiwan, 70457
    • Local Institution - 0298
  • Tainan City, Taiwan, 71004
    • Local Institution - 0300
  • Taipei, Taiwan, 10449
    • Local Institution - 0305
  • Taipei, Taiwan, 11217
    • Local Institution - 0297
• Turkey
  • Adana, Turkey, 01060
    • Local Institution - 0073
  • Ankara, Turkey, 06520
    • Local Institution - 0257
  • Antalya, Turkey, 07070
    • Local Institution - 0075
  • Istanbul, Turkey, 34300
    • Local Institution - 0074
• United Kingdom
  • London, United Kingdom, NW1 2BU
    • Local Institution - 0005
  • Manchester
    • Withington, Manchester, United Kingdom, M20 4BX
      • Local Institution - 0006
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • Local Institution - 0136
  • California
    • Greenbrae, California, United States, 94904
      • Local Institution - 0052
    • Whittier, California, United States, 90603
      • Local Institution - 0051
  • Connecticut
    • Stamford, Connecticut, United States, 06904
      • Local Institution - 0182
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Local Institution - 0150
    • Miami, Florida, United States, 33136
      • Local Institution - 0097
    • Pensacola, Florida, United States, 32504
      • Local Institution - 0149
    • Tallahassee, Florida, United States, 32308
      • Local Institution - 0120
  • Georgia
    • Athens, Georgia, United States, 30607
      • Local Institution - 0054
    • Atlanta, Georgia, United States, 30342
      • Local Institution - 0107
    • Columbus, Georgia, United States, 31904
      • Local Institution - 0056
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Local Institution - 0221
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Local Institution - 0227
  • Maine
    • Topsham, Maine, United States, 04086
      • Local Institution - 0222
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Local Institution - 0146
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • HCA Midwest Division
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Local Institution - 0109
    • Hackensack, New Jersey, United States, 07601
      • Local Institution - 0050
    • New Brunswick, New Jersey, United States, 08903
      • Local Institution - 0180
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Local Institution - 0181
  • New York
    • Bronx, New York, United States, 10461
      • Local Institution - 0041
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Local Institution - 0283
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Institute
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Local Institution - 0053
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 0218
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Local Institution - 0121
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Local Institution - 0224
    • Fredericksburg, Virginia, United States, 22408
      • Local Institution - 0122
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98109
      • Local Institution - 0274

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 then adjuvant ET; Nivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then adjuvant (post-surgery) endocrine therapy of investigator's choice	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; Other: nivolumab placebo; Specified dose on Specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR) Rate	pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.	Up to approximately 37 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR) Rate (PD-L1 >=1%)	pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.	Up to approximately 37 months
Number of Participants With Residual Cancer Burden (RCB)	RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.	Up to approximately 37 months
Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%	RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.	Up to approximately 37 months
Number of Participants With Adverse Events (AEs)	Number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 25 months)
Number of Participants With Serious Adverse Events (SAEs)	Number of participants with any grade serious adverse events (SAE). SAE is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires inpatient hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 25 months)
Number of Participants Who Died	Number of participants who died due to any cause.	Up to approximately 37 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Cancer; Nivolumab; Neoadjuvant; Adjuvant; Primary Breast Cancer; Estrogen Receptor-Positive (ER+); Human Epidermal Growth Factor 2 Negative (HER2-)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Cyclophosphamide; Paclitaxel; Nivolumab
• Other Study ID Numbers: CA209-7FL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No