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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)

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ClinicalTrials.gov Identifier: NCT04109066
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : October 18, 2021
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 October 18, 2021
Actual Study Start Date  ICMJE November 20, 2019
Estimated Primary Completion Date June 20, 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2021)
  • Pathological Complete response (pCR) Using the definition of ypT0/is ypN0 [ Time Frame: approximately 7 months ]
  • Event-Free Survival (EFS) [ Time Frame: up to 10 years ]
Original 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2021)
  • 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 ]
  • pCR using the definition of ypT0 ypN0 [ Time Frame: approximately 7 months ]
  • pCR rate using the definition of ypT0/is [ Time Frame: approximately 7 months ]
  • Objective response rate (ORR) using definition of tumor response rate per radiologic-based assessment [ Time Frame: approximately 7 months ]
  • ORR using definition of tumor response rate per clinic-based physical assessment [ Time Frame: approximately 7 months ]
  • Residual cancer burden (RCB) category status (0, I, II, III) [ Time Frame: approximately 7 months ]
  • Incidence of adverse events (AEs) [ Time Frame: approximately 17 months ]
  • Severity of AEs [ Time Frame: approximately 17 months ]
  • 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 ]
  • 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
 (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 ]
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 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
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 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.
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 placebo 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:

  • 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

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,   China,   Colombia,   Czechia,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Ireland,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   Turkey,   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 October 2021

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