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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)

  • Clinicaltrials.gov identifier

    NCT04109066

  • Recruitment Status

    Active, not recruiting

  • First Posted

    September 30, 2019

  • Last update posted

    July 22, 2022

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.

  • Condition or Disease:Breast Cancer
  • Intervention/Treatment: Biological: nivolumab
    Drug: paclitaxel (PTX)
    Other: nivolumab placebo
    Drug: anthracycline
    Drug: cyclophosphamide
    Drug: Endocrine Therapy
    Procedure: Surgery
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 506 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official 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
  • Actual Study Start Date: November 2019
  • Estimated Primary Completion Date: June 2032
  • Estimated Study Completion Date: June 2032

Arms and interventions

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

Outcome Measures

  • Primary Outcome Measures: 1. Pathological Complete response (pCR) Using the definition of ypT0/is ypN0 [ Time Frame: approximately 7 months ]
  • 2. Event-Free Survival (EFS) [ Time Frame: up to 10 years ]
  • Secondary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: up to 10 years ]
  • 2. Disease-free Survival (DFS) [ Time Frame: up to 10 years ]
  • 3. Distant Metastasis-free survival (DMFS) [ Time Frame: up to 10 years ]
  • 4. pCR using the definition of ypT0 ypN0 [ Time Frame: approximately 7 months ]
  • 5. pCR rate using the definition of ypT0/is [ Time Frame: approximately 7 months ]
  • 6. Objective response rate (ORR) using definition of tumor response rate per radiologic-based assessment [ Time Frame: approximately 7 months ]
  • 7. ORR using definition of tumor response rate per clinic-based physical assessment [ Time Frame: approximately 7 months ]
  • 8. Residual cancer burden (RCB) category status (0, I, II, III) [ Time Frame: approximately 7 months ]
  • 9. Incidence of adverse events (AEs) [ Time Frame: approximately 17 months ]
  • 10. Severity of AEs [ Time Frame: approximately 17 months ]
  • 11. Change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life (QOL) subscale (items 29 and 30) [ Time Frame: up to 52 weeks ]
  • 12. Change from baseline on the EORTC QLQ-C30 physical functioning subscale (items 1 to 5) [ Time Frame: up to 52 weeks ]

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04109066 History of Changes
  • Other Study ID Numbers: CA209-7FL
  • First Posted: September 30, 2019 Key Record Dates
  • Last Update Posted: July 22, 2022
  • Last Verified: July 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Neoadjuvant
    Nivolumab
    Breast Cancer
    Cancer
    Estrogen Receptor-Positive (ER+)
    Human Epidermal Growth Factor 2 Negative (HER2-)
    Adjuvant
    Primary Breast Cancer
  • Additional relevant MeSH terms: Breast Neoplasms
    Neoplasms by Site
    Neoplasms
    Breast Diseases
    Skin Diseases