A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Patients who have histologically confirmed metastatic or unresectable (not amenable to curative therapy) breast cancer may be screened for eligibility. All patients must have HER2 negative breast cancer with the identified PIK3CA mutation and received at least one line of endocrine therapy. The study will consist of a screening phase, a treatment phase, and a post-treatment phase which includes safety, efficacy, and follow-up. The treatment phase will include taking alpelisib daily in combination with continued use of either Fulvestrant or Aromatase Inhibitor per standard of care until disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（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
Alpelisib + Aromatase Inhibitor or Fulvestrant
Subjects will be treated with Alpelisib in combination with either an Aromatase Inhibitor or Fulvestrant per Standard of Care
干预措施: Alpelisib (Drug)
Alpelisib + Aromatase Inhibitor or Fulvestrant
Subjects will be treated with Alpelisib in combination with either an Aromatase Inhibitor or Fulvestrant per Standard of Care
干预措施: Fulvestrant (Drug)
Alpelisib + Aromatase Inhibitor or Fulvestrant
Subjects will be treated with Alpelisib in combination with either an Aromatase Inhibitor or Fulvestrant per Standard of Care
干预措施: Aromatase inhibitor (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From enrollment until the time of disease progression, up to 60 months
To estimate the progression-free survival (PFS) of alpelisib with continued endocrine therapy (aromatase inhibitor or fulvestrant) following progression in patients with hormone receptor positive, HER2 negative, PIK3CA mutant metastatic breast cancer. PFS defined as time from D1 of treatment with alpelisib with endocrine therapy.
次要结局
- Objective Response Rate (ORR)(From enrollment until the time of disease progression, up to 60 months)
- Clinical Benefit Rate (CBR)(From enrollment until the time of disease progression, up to 60 months)
- Duration of Response (DOR)(From enrollment until the time of disease progression, up to 60 months)
- Overall Survival (OS)(From enrollment until the time of death, up to 60 months)
- Safety Profile of alpelisib with continued endocrine therapy(aromatse inhibitor or fulvestrant)(From enrollment until 30 days after completion of study therapy or subject withdrawal, up to seven months)
研究者
Marina N Sharifi
Sponsor-Investigator
Big Ten Cancer Research Consortium