Randomized Phase II Study of Talazoparib Versus Talazoparib Plus Atezolizumab After Palbociclib Combination Endocrine Therapy for Patients with Premenopausal HR+/HER2- Metastatic Breast Cancer Harboring HRD Scar
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- 2nd Progression free survival (PFS)
研究概览
简要总结
This study is a prospective, two-arm, randomized phase II study of talazoparib versus talazoparib plus atezolizumab in ER+ premeonopausal women with metastatic breast cancer harboring HRD scar
1st line treatment: GnRH agonist + Aromatase Inhibitor(AI) + Palbociclib 28 days after the last treatment of 1st line treatment(., randomization for 2nd line treatment is conducte to arm A(Talazoparib+Atezolizumab) and arm B(Talazoparib monotherapy)
详细描述
- st line treatment
- Palbociclib: A capsule will be administered once a day for 21 days and rest for 7 days (1cycle=28days)
- AI treatment: D1~28 days. Take once a day. Prescribed according to local prescribe guideline.
- GnRH agonist: At D1 for every cycle with 4 week (+3days) interval via subcutaneous injection.
(or ET + CDK4/6 inhibitors + GnRH agonist) 2. nd line treatment
28 days after the last treatment of 1st line treatment, randomization for 2nd line treatment is conducte to arm A(Talazoparib+Atezolizumab) and arm B(Talazoparib monotherapy)
- Talazoparib: Take orally once a day at the same time
- Atezolizumab: 1,200mg, at D1 of each cycle. Applicable for arm A only.
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
- 19 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
Atezolizumab+Talazoparib
- st line treatment
- Palbociclib 125mg po D1-21
- AI : Prescribed as per local guideline
- GnRH agonist: Prescribed as per local guideline (or ET + CDK4/6 inhibitors + GnRH agonist)
- nd line treatment
- Talazoparib 1mg po
- Atezolizumab 1200mg IV (3week)
干预措施: Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab (Drug)
Talazoparib
- st line treatment
- Palbociclib 125mg po D1-21
- AI : Prescribed as per local guideline
- GnRH agonist: Prescribed as per local guideline (or ET + CDK4/6 inhibitors + GnRH agonist)
- nd line treatment - Talazoparib 1mg po
干预措施: Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, (Drug)
结局指标
主要结局
2nd Progression free survival (PFS)
时间窗: The time until the time of the first event(the progression of a recorded disease of breast cancer or death from all causes) in 2nd line treatment. Up to 72months
To assess measures of clinical efficacy. It is a measure of the period of survival without disease progression by Kaplan-Meier method.
次要结局
- Toxicity assessment(from the date of informed consent signature to 28 days after last drug administration)
- Composite PFS (1st PFS + 2nd PFS)(The time from the day 1 of first therapy to the time of first event (documented disease progression of breast cancer or death due to any cause) in 1st and 2nd line therapy. Up to 72months)
- Overall survival (OS)(Survival will be measured as the time from the randomization occurs after Progression of 1st line to the date of death. Up to 72months)
- Quality of Life (QoL)(from the date of informed consent signature to 28 days after last drug administration)
研究者
Yeon Hee Park
Clinical Professor
Samsung Medical Center