EUCTR2019-002469-37-IT进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Localized invasive breast ductal carcinoma, confirmed by the local
- •pathologist, that includes either T1c-T2 (tumor size = 2 cm), clinical
- •node stage (cN) 1-cN2, or T3-T4, cN0-cN2. Nodal status must be
- •cytologically confirmed. Note: Inflammatory breast cancer is allowed
- •-ER+ breast cancer and with or without progesterone receptor (PgR)
- •expression (determined on the most recently analyzed tissue sample and
- •tested 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 and must agree to undergo surgery
- •after completion of neoadjuvant therapy
- •-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 840
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 560
排除标准
- •-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 7 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
- •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
研究者
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