NCT05433480进行中（未招募）3 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Fulvestrant Plus BPI-16350 or Plus Placebo in Patients With HR+, HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer With Disease Progression Following Endocrine Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 274
- 试验地点
- 64
- 主要终点
- Investigator-assessed PFS
研究概览
简要总结
This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced，recurrent or metastatic breast cancer with disease progression following endocrine therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Has the pathologically-confirmed diagnosis of locally advanced, recurrent or metastatic, HR positive, HER2 negative Breast Cancer
- •One previous line of chemotherapy for advanced/metastatic disease is allowed
- •Disease Progression following endocrine therapy
- •Have postmenopausal status
- •Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: measurable disease or nonmeasurable bone-only disease
- •ECOG: 0~1
- •Adequate organ function
排除标准
- •Previous treatment with cytotoxic drugs within 4 weeks before enrollment
- •Previous treatment with endocrine or small molecule drug tyrosine kinase inhibitor TKI within 2 weeks before enrollment
- •Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant
- •HER2 positive
- •Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, etc
- •Pregnancy or lactation
- •Other conditions considered not appropriate to participate in this trial by the investigators
研究组 & 干预措施
experimental group
Experimental
Intervention Drug: BPI-16350, Fulvestrant
干预措施: BPI-16350 (Drug)
experimental group
Experimental
Intervention Drug: BPI-16350, Fulvestrant
干预措施: Fulvestrant (Drug)
control group
Placebo Comparator
Intervention Drug: Placebo, Fulvestrant
干预措施: placebo (Drug)
control group
Placebo Comparator
Intervention Drug: Placebo, Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Investigator-assessed PFS
时间窗: up to 3 years
The PFS time is measured from the date of randomization to the date of objective progression or the date of death due to any cause, whichever is earlier.
次要结局
- DCR(up to 3 years)
- AEs and SAEs(up to 3 years)
- OS(up to 5 years)
- ORR(up to 3 years)
- EORTC QLQ-C30(up to 5 years)
- DOR(up to 3 years)
- CBR(up to 3 years)
- IREC-assessed PFS(up to 3 years)
- Evaluate the pharmacokinetics of BPI-16350(Up to 3 cycles(each cycle is 28 days))
研究者
研究点 (64)
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