NCT07354022招募中3 期
A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 912 人开始时间: 2026年5月5日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 912
- 试验地点
- 1
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant 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 - 75 years old;
- •Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
- •Patients with histologically confirmed locally advanced or metastatic breast cancer;
- •Patients with prior adjuvant endocrine resistance following curative-intent surgery;
- •Menstrual status: postmenopausal, perimenopausal, or premenopausal;
- •Presence of evaluable lesions;
- •Organ function must meet required criteria.
排除标准
- •Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
- •Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
- •Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
- •Patients with a history of clinically significant cardiovascular disease;
- •Participants who have not recovered from adverse effects caused by prior therapies;
- •Participants with a history of another malignancy within the past 5 years or currently having another malignancy;
- •Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.
研究组 & 干预措施
HRS-8080 combined with Dalpiciclib
Experimental
干预措施: HRS-8080 Tablet ; Dalpiciclib Isethionate (Drug)
Fulvestrant combined with Dalpiciclib
Active Comparator
干预措施: Fulvestrant injection ;Dalpiciclib Isethionate (Drug)
研究者
研究点 (1)
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