NCT04109066 - Bristol Myers Squibb™

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
Estimated Enrollment: 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

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 ]
Primary Outcome Measures: 2. Event-Free Survival (EFS) [ Time Frame: up to 10 years ]
Secondary Outcome Measures: 1. Overall Survival (OS) [ Time Frame: up to 10 years ]
Secondary Outcome Measures: 2. Disease-free Survival (DFS) [ Time Frame: up to 10 years ]
Secondary Outcome Measures: 3. Distant Metastasis-free survival (DMFS) [ Time Frame: up to 10 years ]
Secondary Outcome Measures: 4. pCR using the definition of ypT0 ypN0 [ Time Frame: approximately 7 months ]
Secondary Outcome Measures: 5. pCR rate using the definition of ypT0/is [ Time Frame: approximately 7 months ]
Secondary Outcome Measures: 6. Objective response rate (ORR) using definition of tumor response rate per radiologic-based assessment [ Time Frame: approximately 7 months ]
Secondary Outcome Measures: 7. ORR using definition of tumor response rate per clinic-based physical assessment [ Time Frame: approximately 7 months ]
Secondary Outcome Measures: 8. Residual cancer burden (RCB) category status (0, I, II, III) [ Time Frame: approximately 7 months ]
Secondary Outcome Measures: 9. Incidence of adverse events (AEs) [ Time Frame: approximately 17 months ]
Secondary Outcome Measures: 10. Severity of AEs [ Time Frame: approximately 17 months ]
Secondary Outcome Measures: 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 ]
Secondary Outcome Measures: 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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

Contact: Recruiting sites have contact information.Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Alabama
University of South Alabama Mitchell Cancer Institute
Mobile

United States, California
Local Institution
Concord

United States, California
Local Institution
Duarte

United States, California
Marin Cancer Care, Inc
Greenbrae

United States, California
Local Institution
Los Angeles

United States, California
Local Institution
Orange

United States, California
Innovative Clinical Research Institute
Whittier

United States, Connecticut
Bennett Cancer Center
Stamford

United States, Florida
Cancer Specialists of North FL
Jacksonville

United States, Florida
University of Miami
Miami

United States, Florida
Local Institution
Orlando

United States, Florida
Sacred Heart Medical Group
Pensacola

United States, Florida
Tallahassee Memorial Cancer Center
Tallahassee

United States, Georgia
University Cancer Blood Ctr
Athens

United States, Georgia
Northside Hospital,Inc.- Central Research Department
Atlanta

United States, Georgia
John B. Amos Cancer Center
Columbus

United States, Illinois
Northwestern Memorial Hospital
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
Scarborough

United States, Maryland
American Oncology Partners of Maryland, PA
Bethesda

United States, Missouri
HCA Midwest Division
Kansas City

United States, New Jersey
Local Institution
Flemington

United States, New Jersey
Summit Medical Group
Florham Park

United States, New Jersey
The Cancer Center At Hackensack University Medical Center
Hackensack

United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick

United States, New Mexico
University of New Mexico Comprehensive Cancer Center
Albuquerque

United States, New York
Montefiore Medical Center
Bronx

United States, North Carolina
Local Institution
Charlotte

United States, North Carolina
Local Institution
Durham

United States, North Carolina
Local Institution
Winston-Salem

United States, Ohio
Local Institution
Canton

United States, Ohio
Local Institution
Cincinnati

United States, Ohio
MetroHealth Medical Center
Cleveland

United States, Ohio
Local Institution
Cleveland

United States, Oregon
Local Institution
Portland

United States, Tennessee
Tennessee Oncology, PLLC - SCRI - PPDS
Chattanooga

United States, Tennessee
Local Institution
Knoxville

United States, Texas
Ft. Worth Center For Cancer Blood Disorders
Fort Worth

United States, Utah
Local Institution
Salt Lake City

United States, Virginia
Local Institution
Fairfax

United States, Virginia
Hematology-Oncology Associates Of Fredricksburg, Inc
Fredericksburg

United States, Virginia
Virginia Cancer Institute
Richmond

United States, Washington
Local Institution
Seattle

Argentina, Buenos Aires
Local Institution
Caba

Argentina, Buenos Aires
Local Institution
Ciudad Autonoma Beunos Aires

Argentina, Buenos Aires
Hospital Britanico De Buenos Aires
Ciudad Autónoma de Buenos Aires

Argentina, Buenos Aires
Local Institution
La Plata

Argentina, Cordoba
Local Institution
Río Cuarto

Argentina, Santa FE
Local Institution
Rosario

Argentina
Clinica Adventista Belgrano
Buenos Aires

Argentina
Instituto Medico Especialazado Alexander Fleming
Caba

Argentina
Local Institution
Cordoba

Argentina
Local Institution
La Rioja

Argentina
Local Institution
Viedma

Australia, New South Wales
Mater Hospital
North Sydney

Australia, New South Wales
Port Macquarie Base Hospital
Port Macquarie

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
Austin Hospital
Heidelberg

Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne

Australia, Victoria
Ballarat Base Hospital
North Ballarat

Austria
Universitaetsklinik F. Frauenheilkunde / Geburtshilfe
Graz

Austria
Med. Universitaet Innsbruck
Innsbruck

Austria
Landeskrankenhaus-Universitaetsklinik fuer Innere Medizin III
Salzburg

Austria
Medizinische Universitaet Wien
Wien

Belgium
Grand Hôpital de Charleroi
Charleroi

Belgium
Universitair Ziekenhuis Antwerpen
Edegem

Belgium
UZ Gent-Medical oncology
Gent

Belgium
Universitair Ziekenhuis Brussel - PIN
Jette

Belgium
CHU de Liège
Liege

Brazil, Ceara
Oncocentro Servico Medicos e Hospitalares Ltda
Fortaleza

Brazil, Distrito Federal
Hospital Sirio Libanes
Brasilia

Brazil, Goias
Local Institution
Goiania

Brazil, Minas Gerais
Universidade Federal De Minas Gerais
Belo Horizonte - Mg

Brazil, Minas Gerais
Local Institution
Juiz de Fora

Brazil, RIO Grande DO SUL
Associacao Hospital de Caridade Ijui
Ijui

Brazil, RIO Grande DO SUL
Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita
Port Alegre

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, Rio Grande Do Sul
Hospital Sao Lucas Da Pucrs
Porto Alegre

Brazil, RIO Grande DO SUL
Local Institution
Santa Cruz do Sul

Brazil, Sao Paulo
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos

Brazil, SAO Paulo
Faculdade De Medicina Do Abc
Santo Andre

Brazil, SAO Paulo
Local Institution
São Paulo

Brazil
COI Clinicas Oncologicas Integradas SA
Rio de Janeiro

Brazil
Centro de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria
Sao Paulo

Brazil
Hospital Municipal Vila Santa Catarina
Sao Paulo

Canada, Ontario
Local Institution
Thunder Bay

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montreal

Canada, Quebec
Centre Hospitalier de l'Université de Montréal-Breast Cancer
Montréal

Canada, Quebec
Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS
Sherbrooke

Chile, Coquimbo
Local Institution
La Serena

Chile, Metropolitana
Centro de Investigacion Clinica Bradford Hill
Santiago de Chile

Chile, Metropolitana
Hospital Clinico Pontificia Universidad Catolica De Chile
Santiago Region Metropolitana

Chile, Valparaiso
Oncocentro Apys
Vina del Mar

China, Anhui
Local Institution
Bengbu

China, Anhui
Local Institution
Hefei

China, Beijing
Local Institution
Beijing

China, Chongqing
Local Institution
Chongqing

China, Fujian
Local Institution
Xiamen

China, Guangdong
Local Institution
Guangzhou

China, Hebei
Local Institution
Shjiazhuang

China, Heilongjiang
Local Institution
Harbin

China, Henan
Local Institution
Zhengzhou

China, Hubei
Local Institution
Wuhan

China, Jilin
Local Institution
Changchun

China, Liaoning
Local Institution
Shenyang

China, Shan1xi
Local Institution
XiAn

China, Shandong
Local Institution
Jinan

China, Shandong
Local Institution
Qingdao

China, Shandong
Local Institution
YanTai

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution
Chengdu

China, Tianjin
Local Institution
Tianjin

China, Xinjiang
Local Institution
Urumqi

China, Zhejiang
Local Institution
Hangzhou

China
Local Institution
Chengdu

Colombia, Bogota
Local Institution
Colombia

Colombia
Local Institution
Barranquilla

Colombia
Local Institution
Bogotá

Colombia
Local Institution
Cali

Colombia
Local Institution
Floridablanca

Colombia
Local Institution
Monteria

Colombia
Local Institution
Pereira

Colombia
Local Institution
Rionegro, Antioquia

Czechia
Local Institution
Chomutov

Czechia
Klinika onkologie a radioterapie
Hradec Kralove

Czechia
Komplexni onkologicke centrum
Novy Jicin

Czechia
Onkologicka klinika
Olomouc

Czechia
Radioterapeuticka a onkologicka klinika FNKV
Praha 10

Denmark
Local Institution
Aarhus N

Denmark
Local Institution
Herlev

Denmark
Local Institution
Kobenhavn O

Denmark
Local Institution
Naestved

Finland
Local Institution
Helsinki

Finland
Local Institution
Tampere

France
Local Institution
Bayonne

France
Chu Jean Minjoz
Besancon

France
Hopital Morvan
Brest

France
Centre Jean Perrin
Clermont-ferrand

France
Clinique Victor Hugo
Le Mans

France
Hopital Prive Jean Mermoz
Lyon

France
Institut du Cancer de Montpellier
Montpellier Cedex 5

France
Hopital Europeen Georges Pompidou
Paris

France
Hôpital Privé Des Côtes d'Armor
Plerin

France
Institut De Cancerologie De L Ouest
Saint Herblain Cedex

France
Local Institution
Strasbourg

France
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon

France
Institut Gustave Roussy
Villejuif

Germany
Helios Klinikum Berlin-Buch
Berlin

Germany
Local Institution
Berlin

Germany
Universitaetsklinikum Carl Gustav Carus
Dresden

Germany
Local Institution
Erlangen

Germany
Universitaetsklinikum Essen
Essen

Germany
Universitatsklinikum Frankfurt
Frankfurt

Germany
Agaplesion Diakonieklinikum
Hamburg

Germany
Universitaetsklinik Heidelberg
Heidelberg

Germany
Universitaetsklinikum d. Saarlandes
Homburg

Germany
Universitaetsklinikum Koeln
Koeln

Germany
Universitatsklinikum Leipzig
Leipzig

Germany
Evang. Krankenhaus Bethesda
Moenchengladbach

Germany
Klinikum der Universitaet Muenchen
Muenchen

Germany
Uni Frauenklinikum Suedstadt
Rostock

Germany
CaritasKlinikum Saarbruecken.
Saarbruecken

Germany
MVZ-Onkologie Velbert GbR
Velbert

Germany
Universitaetsklinikum Wuerzburg
Würzburg

Hong Kong
Local Institution
Hong Kong

Ireland, Dublin
St. James'S Hospital
Dublin 8

Ireland
Cork University Hospital
Cork

Ireland
Beaumont Hospital
Dublin

Italy
Local Institution
Bergamo

Italy
Local Institution
Brindisi

Italy
Local Institution
Catania

Italy
Azienda Ospedaliero-Universitaria Mater Domini
Catanzaro

Italy
Local Institution
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
Local Institution
Prato

Italy
Local Institution
Roma

Italy
Istituto Clinico Humanitas
Rozzano (MI)

Korea, Republic of
Local Institution
Seoul

Mexico, BAJA California
Local Institution
Tijuana

Mexico, Distrito Federal
Local Institution
Mexico City

Mexico, Distrito Federal
Local Institution
Tlalpan

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico, Yucatan
Local Institution
Merida

Mexico
Local Institution
Campeche

Mexico
Local Institution
Chihuahua

Mexico
Local Institution
Colima

Mexico
Local Institution
Oaxaca

Netherlands
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam

Netherlands
Amphia Ziekenhuis
Breda

Netherlands
Deventer Ziekenhuis
Deventer

Netherlands
Local Institution
Rotterdam

Netherlands
Universitair Medisch Centrum Utrecht
Utrecht

Poland
Oddzial Dzienny Chemioterapii
Koszalin

Poland
Local Institution
Krakow

Poland
Klinika Onkologii CZMP
Lodz

Poland
Local Institution
Opole

Poland
Klinika Nowotworow Piersi i Chirurgii Rekonstrukcyjnej
Warszawa

Portugal
Local Institution
Lisboa

Portugal
Local Institution
Porto

Puerto Rico
Ponce Medical School Foundation
Ponce

Puerto Rico
Local Institution
San Juan

Romania
Local Institution
Bucharest

Romania
Local Institution
Bucuresti

Romania
Local Institution
Craiova

Romania
Local Institution
Floresti

Romania
Local Institution
Suceava

Russian Federation
Local Institution
Krasnodar

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Ryazan

Russian Federation
Local Institution
Sochi

Singapore
Local Institution
Singapore

Spain
Local Institution
Barcelona

Spain
Local Institution
Elche (alicante)

Spain
Local Institution
Madrid

Spain
Local Institution
Malaga

Spain
Local Institution
Santiago Compostela

Spain
Local Institution
Sevilla

Switzerland
University Hospital Basel
Basel

Switzerland
CHUV
Lausanne

Switzerland
Onkologiezentrum Thun-Berner Oberland Spital Sts Ag
Thun

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Tainan City

Taiwan
Local Institution
Tainan

Taiwan
Local Institution
Taipei

Turkey
Local Institution
Adana

Turkey
Local Institution
Ankara

Turkey
Local Institution
Antalya

Turkey
Local Institution
Istanbul

United Kingdom, Glamorgan
Local Institution
Swansea

United Kingdom, Manchester
The Christie NHS Foundation Trust
Withington

United Kingdom
Local Institution
Coventry

United Kingdom
Local Institution
Headington

United Kingdom
Local Institution
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: October 18, 2021
Last Verified: October 2021
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: Adjuvant
Primary Breast Cancer
Neoadjuvant
Human Epidermal Growth Factor 2 Negative (HER2-) Estrogen Receptor-Positive (ER+)
Cancer
Breast Cancer
Nivolumab
Additional relevant MeSH terms: Breast Neoplasms

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Condition Categories

Clinical Trials of Interest

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)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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Condition Categories

Clinical Trials of Interest

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)

Study Description

Detailed Description

Study Design

Arms and interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Criteria

Contacts and Locations

Contacts

Locations

Sponsors and Collaborators

Investigators

More Information

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