EUCTR2019-002469-37-PT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
- •a)Males and females, aged at least 18 years or age of majority.
- •b)Female or male participants must have histologically confirmed unilateral invasive breast carcinoma, with the following characteristics (i, ii, iii):
- •i) Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes either T1c-T2, clinical node stage (cN)1-cN2, or T3 T4, cN0-cN2. Inflammatory breast cancer is allowed.
- •ii) Participants must have ER+, HER2- BC meeting below characteristics (1,2):
- •(1)ER+ breast cancer and with or without progesterone-receptor (determined by central laboratory as defined in the relevant American Society of Clinical Oncology [ASCO]-College of American Pathologists [CAP] Guidelines).
- •(2)HER2- breast cancer tested in a local laboratory defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+ (determined by local laboratory as defined in the relevant ASCO- CAP Guidelines).
- •iii)Participant must have Protocol-specified disease grade 2 or 3 according to the most recent ASCO-CAP guidelines.
- •c) Participant must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1.
- •d)Participants provide tumor tissue at baseline (collected = 60 days prior to enrollment) and at surgery.
- •e)Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.
- •f)WOCBP participants must agree to use effective contraception during the Treatment Period and for at least 12 months for participants who receive cyclophosphamide, or 7 months for participants who do not receive cyclophosphamide, after the last dose of study treatment with nivolumab or nivolumab placebo, whichever is longer.
- •g)Male participants must agree to use contraception and refrain from donating sperm during the Treatment Period and for at least 12 months for participants who receive cyclophosphamide, or 7 months for participants who do not receive cyclophosphamide, after the last dose of study treatment with nivolumab or nivolumab placebo, whichever is greater.
- •h)Participants must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF, in accordance with regulatory and institutional guidelines
- •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
- •a) Women who are breastfeeding.
- •b) Participants who are pregnant or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study.
- •c) History of ipsilateral invasive BC, regardless of treatment, ipsilateral ductal carcinoma in situ treated with radiation, or contralateral invasive BC, at any time.
- •d) Definitive clinical or radiologic evidence of metastatic disease.
- •e) Multicentric breast cancer.
- •f) Bilateral invasive BC.
- •g) History of ductal carcinoma in situ (DCIS), unless a complete remission was achieved at least 2 years prior to study start and no additional therapy is required or anticipated to be required during the study, or a history of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed > 5 years prior to diagnosis of the current BC.
- •h) Participants with = Grade 1 peripheral neuropathy.
- •i) 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 Tcell co-stimulation or checkpoint pathways.
- •j) Any treatment, local or systemic, including prior chemotherapy, endocrine therapy, targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to enrollment.
研究者
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