Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab: A Phase III Randomized Trial. Sponsor: Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, Università di Padova
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 474
- 试验地点
- 70
- 主要终点
- Disease free survival
研究概览
简要总结
Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients:
- Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy .
- Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy.
详细描述
- to determine whether 1 year of adjuvant Avelumab improves disease-free survival (DFS) compared to observation in patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including surgery of the primary tumor and neo- or adjuvant chemotherapy (Stratum A [surgery of the primary tumor followed by adjuvant chemotherapy] and Stratum B [neoadjuvant chemotherapy followed by surgery] combined).
- to determine whether 1 year of adjuvant Avelumab improves disease-free survival (DFS) compared to observation in patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery (Stratum B).
- to determine whether Avelumab improves overall survival (OS) compared to observation in patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including surgery of the primary tumor and neo- or adjuvant chemotherapy.
- to determine whether 1 year of adjuvant Avelumab improves disease-free survival (DFS) compared to observation in PD-L1-positive (as determined by a companion diagnostic test under development) patients with high-risk primary triple negative breast cancer who have completed treatment with curative intent including surgery of the primary tumor and neo- or adjuvant 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm Avelumab
Avelumab 10 mg/kg I.V. q2w for 1 year (52 weeks)
干预措施: MSB0010718C (Drug)
结局指标
主要结局
Disease free survival
时间窗: Up to 5 years after randomization
DFS is defined as the time from randomization to locoregional invasive recurrence, second primary invasive breast cancer, other second primary cancer (excluding in-situ cancers), distant metastasis or death from any cause.
Disease free survival in PD-L1-positive patients
时间窗: Up to 5 years after randomization
DFS is defined as the time from randomization to locoregional invasive recurrence, second primary invasive breast cancer, other second primary cancer (excluding in-situ cancers), distant metastasis or death from any cause.
次要结局
- Overall survival(Up to 5 years after randomization)
- Safety profile(From Baseline up to 5 years after randomization)