NCT06954961招募中3 期
A Randomized, Parallel-controlled, Open-label, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of D-0502 With Fulvestrant in Patients With Previously Treated ER-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS) assessed by Independent Review Committee (IRC)
研究概览
简要总结
This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug.
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
- •Subjects pathologically confirmed with ER-positive, HER2-negative breast cancer;
- •Subjects with locally advanced (unresectable) or metastatic breast cancer who have disease recurrence during or after adjuvant endocrine therapy, or whose disease has progressed after 1-2 lines of systemic endocrine therapy;
- •Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria; in the absence of measurable lesions, subjects with evaluable bone lesions [osteolytic or mixed (osteolytic + osteogenic) bone lesions] are also acceptable. Lesions that have been previously treated with radiotherapy or other local therapy can be regarded as measurable lesions only if there is disease progression as confirmed by imaging examination;
- •Expected survival time ≥ 12 weeks;
排除标准
- •Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases. Subjects with a history of brain metastases who are clinically stable and have no CNS disease progression confirmed by brain MRI or CT (if MRI is not appropriate) can be enrolled (MRI or CT examination must be conducted at least 4 weeks after the last brain radiotherapy);
- •Subjects with locally advanced or metastatic breast cancer who have previously received more than 2 prior systemic chemotherapy;
- •Subjects are unsuitable for endocrine therapy judged by the investigator, including uncontrolled pleural effusion, ascites or pericardial effusion;
- •Subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases;
- •Prior treatment with a selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA), such as fulvestrant, GDC-9545, AZD9833, SAR-439859, Zn -c5, LX-039, HS234, etc.;
- •Pregnant or lactating females;
研究组 & 干预措施
D-0502
Experimental
干预措施: D-0502 (Drug)
Fulvestrant
Active Comparator
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
时间窗: From enrollment to the end of treatment, up to 2 years
次要结局
- Progression free survival (PFS) -assessed by investigators(From enrollment to the end of treatment, up to 2 years)
- Objective response rate (ORR) -assessed by IRC and investigators(From enrollment to the end of treatment, up to 2 years)
- Clinical benefit rate (CBR) -assessed by IRC and investigators(From enrollment to the end of treatment, up to 2 years)
- Disease control rate (DCR)-assessed by IRC and investigators(From enrollment to the end of treatment, up to 2 years)
- Clearance (Cl) of D-0502(on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days))
- Overall Survival (OS)(From end of treatment to end of study, about 2 years)
- Number of participants with adverse events/serious adverse events and abnormal laboratory test results(From enrollment to 30 days after last dose)
- Volume of distribution (Vd) of D-0502(on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days))
研究者
研究点 (2)
Loading locations...
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