A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants
研究概览
简要总结
This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.
详细描述
The study is a phase IIIb, multicenter, single-arm, open-label study designed to evaluate the clinical effectiveness in a real-world setting of olaparib monotherapy in patients with confirmed germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations. This study will generate additional data to support other olaparib studies, which may help inform and guide clinical practice. Physician defined the progression-free survival (PFS) for gBRCAm patients is the primary outcome measure. Based on the prevalence of gBRCA1/2 mutations, it is estimated that up to 1400 patients may require screening in order to identify 250 gBRCA mutated patients and 20 sBRCA mutated patients. Patients will be administered two olaparib 150mg tablets in morning and evening of every day after a light meal. Dose reductions may be required for olaparib treatment related toxicities. Patients should continue to receive study treatment until documented physician-defined disease progression as assessed by the investigator (gBRCA mutated patients), RECIST1.1 disease progression (sBRCA mutated patients) or unacceptable toxicity, or for as long as they do not meet any other discontinuation criteria. A positive benefit/risk profile is expected and no ethical issues are identified from exposing patients to olaparib within the planned clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（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 150mg tablets administered orally twice daily continuously
干预措施: Olaparib (Drug)
结局指标
主要结局
Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants
时间窗: At every visit until the earliest of disease progression, death or end of study (up to 3 years)
The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting through assessment of PFS in germline BRCA mutated patients was evaluated. PFS is defined as the time from first dose of olaparib to the date of progression or death from any cause. In this study, disease progression in gBRCAm patients will be based on Investigator assessment, i.e. radiological ( e.g. RECIST) progression, symptomatic progression, or clear progression of non-measurable disease, as long as progression can be documented.
次要结局
- Time to First Subsequent Treatment or Death (TFST) in Germline BRCA Mutated Participants(At every visit until start of first subsequent anticancer treatment or death or end of study (up to 3 years))
- Time to Second Subsequent Treatment or Death (TSST) in Germline BRCA Mutated Participants(At every visit until start of second subsequent anticancer treatment or death or end of study (up to 3 years))
- Overall Survival (OS) in Germline BRCA Mutated Participants(At every visit and until death or end of study (up to 3 years))
- Time to Study Treatment Discontinuation or Death (TDT) in Germline BRCA Mutated Participants(At every visit and until discontinuation of study treatment or death or end of study (up to 3 years))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Screening (Day -28 to Day -1) until post DCO [up to 3 years])
- Time to Second Progression or Death (PFS2) in Germline BRCA Mutated Participants(At every visit until second progression or death or end of study (up to 3 years))
- Clinical Response Rate (CRR) in Germline BRCA Mutated Participants(At every visit until disease progression or death or end of study (up to 3 years))
- Duration of Clinical Response (DoCR) in Germline BRCA Mutated Participants(At every visit until disease progression or death or end of study (up to 3 years))