NCT07207070招募中3 期
A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.
Risen (Suzhou) Pharma Tech Co., Ltd.2 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2025年11月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Blind Independent Central Review (BICR) assessed PFS based on RECIST v1.1 (BICR-PFS)
研究概览
简要总结
This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with PIK3CA-mutated, HR-positive, HER2-negative recurrent or metastatic breast cancer.
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
- All
- 接受健康志愿者
- 是
入选标准
- •At the time of signing the consent form, age must be between 18 and 75 years old, males and females;
- •Patients with unresectable PIK3CA-mutated HR-positive HER2-negative recurrent or metastatic breast cancer;
- •Consent to provide tumour tissue or blood samples to determine the PIK3CA mutation status;
- •ECOG 0 or 1;
- •At least one measurable lesion as per RECIST v1.1, or only bone metastases;
- •Expected survival≥12 weeks;
- •Good organ function;
- •Patients voluntarily join the study and sign the informed consent;
排除标准
- •Previously treated with fulvestrant or PI3K/AKT/mTOR inhibitors;
- •Presence of untreated or active central nervous system (CNS) metastases;
- •Presence of significant clinical symptoms or uncontrolled pleural effusion, ascites, or pericardial effusion that require repeated drainage (once a month or more frequently);
- •Untreated spinal cord compression, or previously treated spinal cord compression without clinical evidence of disease stability for at least 4 weeks prior to the first study treatment;
- •Have received other anti-tumor treatment within 2-4 weeks before the first dose;
- •Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1;
- •Coexisting uncontrolled accompanying diseases, including but not limited to: history of type I diabetes or uncontrolled type II diabetes, presence of active infection, severe cardiovascular or cerebrovascular diseases, etc;
- •Having another malignant tumour within the last 5 years prior to the first study treatment, except for malignancies that are expected to be cured after treatment;
- •Active hepatitis B or C;
- •Known hypersensitivity to any of the study drugs or their excipients;
- •Pregnant or breastfeeding females;
- •Presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participation in the study, affect treatment compliance, or interfere with study results, as judged by the investigator;
研究组 & 干预措施
JS105+Dalpiciclib+Fulvestrant
Experimental
Patients will receive JS105, Dalpiciclib and Fulvestrant.
干预措施: JS105 (Drug)
JS105+Dalpiciclib+Fulvestrant
Experimental
Patients will receive JS105, Dalpiciclib and Fulvestrant.
干预措施: Dalpiciclib (Drug)
JS105+Dalpiciclib+Fulvestrant
Experimental
Patients will receive JS105, Dalpiciclib and Fulvestrant.
干预措施: Fulvestrant 50 Mg/mL Intramuscular Solution (Drug)
Dalpiciclib+Fulvestrant
Active Comparator
Patients will receive Dalpiciclib and Fulvestrant.
干预措施: Dalpiciclib (Drug)
Dalpiciclib+Fulvestrant
Active Comparator
Patients will receive Dalpiciclib and Fulvestrant.
干预措施: Fulvestrant 50 Mg/mL Intramuscular Solution (Drug)
结局指标
主要结局
Blind Independent Central Review (BICR) assessed PFS based on RECIST v1.1 (BICR-PFS)
时间窗: Up to 3.5 years
PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first).
次要结局
- Overall Survival (OS)(Up to 5 years)
- Investigator-assessed Progression-Free Survival (PFS)(Up to 3.5 years)
- 1-year and 2-year Progression-Free Survival (PFS) rate(Up to 3.5 years)
- Objective Response Rate (ORR)(Up to 5 years)
- Duration of Objective Response (DOR)(Up to 5 years)
- Disease Control Rate(DCR)(Up to 5 years)
- Adverse Event(Up to 5 years)
- Plasma Concentration of JS105(Up to 3.5 years)
研究者
研究点 (2)
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