NCT07024173招募中3 期
A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy
Shandong Suncadia Medicine Co., Ltd.4 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年7月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Progression free survival (PFS) evaluated by the blinded independent central review (BICR).
研究概览
简要总结
This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous 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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 75 years old (including both values).
- •ECOG Physical Strength Status (PS) : 0 to 1 point.
- •Patients with locally advanced or metastatic breast cancer confirmed by histology.
- •Patients previously received 1-2 lines of endocrine therapy.
- •Expected survival > 6 months.
- •The functional level of the organs must meet the requirements.
- •Subjects that voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.
排除标准
- •Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.
- •A history of severe clinical cardiovascular diseases.
- •Patients with uncontrollable tumor-related pain as judged by investigators.
- •Severe infection exists within 4 weeks before the first study administration.
- •Patients with clinically significant endometrial abnormalities.
- •Untreated active hepatitis.
- •Patients known to be allergic to HRS-8080 components.
- •Pregnant and lactating women, or those planning to become pregnant during the study period.
研究组 & 干预措施
HRS-8080 Group
Experimental
干预措施: HRS-8080 Tablet (Drug)
Fulvestrant Group
Active Comparator
干预措施: Fulvestrant injection (Drug)
Exemestane in combination with Everolimus Group
Active Comparator
干预措施: Exemestane tablets (Drug)
Exemestane in combination with Everolimus Group
Active Comparator
干预措施: Everolimus Tablets (Drug)
Exemestane or Anastrozole or Letrozole Group
Active Comparator
干预措施: Letrozole Tablets (Drug)
Exemestane or Anastrozole or Letrozole Group
Active Comparator
干预措施: Exemestane tablets (Drug)
Exemestane or Anastrozole or Letrozole Group
Active Comparator
干预措施: Anastrozole Tablets (Drug)
结局指标
主要结局
Progression free survival (PFS) evaluated by the blinded independent central review (BICR).
时间窗: Approximately 2 years.
次要结局
- Overall response rate (ORR).(Approximately 2 years.)
- Clinical benefit rate (CBR).(Approximately 2 years.)
- Duration of response (DOR).(Approximately 2 years.)
- Overall survival (OS).(Approximately 3 years.)
- Adverse events (AEs).(Approximately 2 years.)
- Serious adverse events (SAEs).(Approximately 2 years.)
- Progression free survival (PFS) evaluated by investigators.(Approximately 2 years.)
研究者
研究点 (4)
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