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Trial record 1 of 1 for:    NCT04109066
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Study of Nivolumab Versus Placebo in Participants With High-Risk Breast Cancer (CheckMate 7FL)

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ClinicalTrials.gov Identifier: NCT04109066
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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

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Study Type : Interventional  (Clinical Trial)
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 : October 25, 2019
Estimated Primary Completion Date : June 20, 2032
Estimated Study Completion Date : June 20, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Nivolumab

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 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




Primary Outcome Measures :
  1. Pathological Complete response (pCR) Pathological Complete response (pCR) Using the definition of ypT0/Tis 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. Pathological Complete Response (pCR) using the definition of ypT0ypN0 [ Time Frame: approximately 7 months ]
  5. Pathological Complete Response (pCR) rate using the definition of ypT0/is [ Time Frame: approximately 7 months ]
  6. Objective Response Rate (ORR) [ Time Frame: approximately 7 months ]
  7. Breast Conserving Surgery (BCS) rate [ Time Frame: approximately 7 months ]
  8. Number of participants experiencing an adverse event (AE) [ Time Frame: approximately 17 months ]
  9. 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 ]
  10. Change from baseline on the EORTC QLQ-C30 physical functioning subscale (items 1 to 5) [ Time Frame: up to 52 weeks ]


Information from the National Library of Medicine

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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:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109066


Contacts
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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 #.

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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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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: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Nivolumab
Breast Cancer
Cancer
Estrogen Receptor-Positive (ER+)
Human Epidermal Growth Factor 2 Negative (HER2-)
Neoadjuvant
Adjuvant
Primary Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Nivolumab
Estrogens
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists