NCT04613674已完成3 期
A Multicentre, Randomized, Double-blind, Parallel-controlled Phase Ⅲ Study to Evaluate Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Patients With Early or Locally Advanced Triple Negative Breast Cancer (TNBC).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 441
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC). Participants will be randomized in a 1:1 ratio to Arm A (camrelizumab +chemotherapy) or Arm B (placebo + chemotherapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG Performance Status of 0-
- •Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
- •Tumor stage: II-III.
- •Adequate hematologic and organ function.
- •Must be willing to use an adequate method of contraception for the course of the study.
排除标准
- •Has a history of breast cancer.
- •Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- •Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
- •Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4].
- •Has a diagnosis of immunodeficiency or autoimmune diseases.
- •Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.
- •Severe pulmonary or cardiac disease.
- •Known active hepatitis C virus, or known active hepatitis B virus.
- •History of organ or bone marrow transplantation.
- •Pregnant or breast-feeding women.
研究组 & 干预措施
Arm A
Experimental
干预措施: Camrelizumab Plus Chemotherapy (Drug)
Arm B
Experimental
干预措施: placebo+chemotherapy (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery.
时间窗: Up to approximately 24 weeks
次要结局
- Event-free Survival (EFS) as assessed by Investigator.(At least 2 years)
- Distant Disease-free Survival (DDFS) as assessed by Investigator(At least 2 years)
- Objective response rate (ORR) in accordance with RECIST v1.1(Up to approximately 24 weeks)
- Percentage of Participants with Adverse Events (AEs)(Up to approximately 67 weeks)
- Disease-free Survival (DFS) as assessed by Investigator(At least 2 years)
研究者
研究点 (1)
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