Neoadjuvant Olaparib and Durvalumab for Patients With BRCA-associated Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- rate of pathological complete response (pCR) at the time of surgery
研究概览
简要总结
This is a multicenter randomized phase ll clinical trial to evaluate the pathological complete response (pCR) in the tumour burden (primary and lymph nodes) with olaparib alone or in the olaparib and durvalumab arm in TNBC patients candidate for neoadjuvant strategy showing a t/gBRCAmut or BRCAness/HRD profile.
详细描述
Eligible patients will be registered for central testing of BRCA mutatinal status and HRD/BRCAness profile with central review of ER, PgR, TILs and PD-L1.
Eligible patients will be randomly assigned to either olparib or olaparib and durvalumab (=neoadjuvant treatment) in a 1:1 ratio. The treatment duration in both arms will last 16 weeks and both treatments are considered as experimental treatments in this study.
After completion of neoadjuvant systemic treatment, patients will undergo surgery and followed-up for 2 years after investigational drug discontinuation. After surgery, adjuvant treatment will be left at the investigator's decision.
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
Olaparib
Olaparib treatment for a total of 16 weeks
干预措施: olaparib (Drug)
Olaparib and durvalumab
Olaparib and durvalumab treatment for a total of 16 weeks
干预措施: olaparib (Drug)
Olaparib and durvalumab
Olaparib and durvalumab treatment for a total of 16 weeks
干预措施: Durvalumab (Drug)
结局指标
主要结局
rate of pathological complete response (pCR) at the time of surgery
时间窗: 5 years from first patient in
pCR is defined as the absence of invasive residual disease in the breast and in the axillary lymph nodes (ypT0/is ypN0).
次要结局
- Breast conservation rate(7.5 years from first patient in)
- Other pathological response(7.5 years from first patient in)
- Probability of being event-free at 2 years(7.5 years from first patient in)
- Treatment response rate according to RECIST v1.1(7.5 years from first patient in)
- Global health status/QoL score(7.5 years from first patient in)
- 2-year overall survival (OS) rate(7.5 years from first patient in)
- Surgery rate(7.5 years from first patient in)
- Safety(7.5 years from first patient in)
- Score on the Systemic side effects scale(7.5 years from first patient in)