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Study of Nivolumab Versus Placebo in Participants With High-Risk Breast Cancer (CheckMate 7FL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109066
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE September 27, 2019
First Posted Date  ICMJE September 30, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE October 25, 2019
Estimated Primary Completion Date June 20, 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • Pathological Complete response (pCR) Pathological Complete response (pCR) Using the definition of ypT0/Tis ypN0 [ Time Frame: approximately 7 months ]
  • Event-Free Survival (EFS) [ Time Frame: up to 10 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • Overall Survival (OS) [ Time Frame: up to 10 years ]
  • Disease-free Survival (DFS) [ Time Frame: up to 10 years ]
  • Distant Metastasis-free survival (DMFS) [ Time Frame: up to 10 years ]
  • Pathological Complete Response (pCR) using the definition of ypT0ypN0 [ Time Frame: approximately 7 months ]
  • Pathological Complete Response (pCR) rate using the definition of ypT0/is [ Time Frame: approximately 7 months ]
  • Objective Response Rate (ORR) [ Time Frame: approximately 7 months ]
  • Breast Conserving Surgery (BCS) rate [ Time Frame: approximately 7 months ]
  • Number of participants experiencing an adverse event (AE) [ Time Frame: approximately 17 months ]
  • Change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-C30) global health status/quality of life (QOL) subscale (items 29 and 30) [ Time Frame: up to 52 weeks ]
  • Change from baseline on the EORTC QLQ-C30 physical functioning subscale (items 1 to 5) [ Time Frame: up to 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Nivolumab Versus Placebo in Participants With High-Risk Breast Cancer
Official Title  ICMJE 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
Brief Summary A randomized multi-arm study evaluating the safety and efficacy of nivolumab versus placebo in combination with paclitaxel in participants with ER+/HER2- breast cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Biological: nivolumab
    Specified Dose on Specified days
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: nivolumab
    • Drug: paclitaxel (PTX)
    • Drug: anthracycline
    • Drug: cyclophosphamide
    • Drug: Endocrine Therapy
    • Procedure: Surgery
  • 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 with adjuvant (post-surgery) endocrine therapy of investigator's choice
    Interventions:
    • Drug: paclitaxel (PTX)
    • Other: nivolumab placebo
    • Drug: anthracycline
    • Drug: cyclophosphamide
    • Drug: Endocrine Therapy
    • Procedure: Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2019)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 20, 2032
Estimated Primary Completion Date June 20, 2032   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Participant has untreated, unilateral invasive, histologically confirmed, localized invasive breast ductal carcinoma that includes either T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is allowed.
  • Participant has centrally confirmed ER+ invasive breast cancer with or without progesterone receptor expression, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.
  • Participant must agree to provide tumor tissue at baseline and at surgery.
  • Participant must be deemed eligible for neoadjuvant chemotherapy.
  • Participant must be deemed eligible for surgery and must agree to undergo surgery after completion of neoadjuvant therapy.
  • Women and men must agree to follow instructions for methods of contraception.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1.

Exclusion Criteria:

  • Participant who is 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, targeted therapy, and/or radiation administered for the currently diagnosed breast cancer, or where upfront chemotherapy is judged clinically inappropriate as optimal neoadjuvant treatment.
  • 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, or history of allergy, or hypersensitivity to study medication.
  • Participant has 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.

Other inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   Czechia,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Ireland,   Mexico,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Romania,   Singapore,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04109066
Other Study ID Numbers  ICMJE CA209-7FL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP