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(CheckMate 7FL: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 7FL) - Nivo/Placebo with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in ER+/HER2-Breast Cancer

Bristol-Myers Squibb International Corporation0 个研究点目标入组 831 人开始时间: 2019年12月20日最近更新: 2024年4月2日

试验速览

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•-Localized invasive breast ductal carcinoma, confirmed by the local
•pathologist, that includes either T1c (tumor size = 2cm)-T2 (tumor size> 2 cm), node stage N1-N2, or T3-T4 node stage N0-N2. Axillary lymph node status must be assessed by fine needle biopsy or core biopsy if there is suspicion for positive axillary lymph
•node(s)radiographically
•-ER+ breast cancer 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
•-Must agree to provide primary breast tumor tissue at baseline and at
•-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
•Other protocol-defined inclusion criteria apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1122
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 748

•-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
•-Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to
•-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 costimulation
•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
•Other protocol-defined exclusion criteria apply

发起方