NCT07111832招募中3 期
A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).
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
- •Age 18-75 years old (including both ends), female.
- •Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.
- •Expected survival ≥ 12 weeks.
- •Have adequate renal and hepatic function.
- •Patients voluntarily joined the study and signed the informed consent.
排除标准
- •Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy.
- •Have other malignancies within the past 5 years.
- •Presence with uncontrollable third space effusion.
- •Have undergone other anti-tumor treatment within 4 weeks before the first dose.
- •A history of immunodeficiency.
- •Clinically significant cardiovascular diseases.
- •Known or suspected interstitial lung disease.
- •Known hereditary or acquired bleeding tendency.
- •Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade
- •Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products.
- •Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.
研究组 & 干预措施
SHR-A1811 and SHR-1316 Group
Experimental
干预措施: SHR-A1811 for Injection (Drug)
SHR-A1811 and SHR-1316 Group
Experimental
干预措施: SHR-1316 Injection (Drug)
Toripalimab and Nab-paclitaxel Group
Active Comparator
干预措施: Toripalimab Injection (Drug)
Toripalimab and Nab-paclitaxel Group
Active Comparator
干预措施: Paclitaxel for Injection (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: An average of 3 year.
次要结局
- Overall response (OS) rate evaluated by investigators(An average of 3 year.)
- Clinical benefit rate (CBR) evaluated by investigators(An average of 3 year.)
- Duration of response (DoR) evaluated by investigators(An average of 3 year.)
- Progression-free survival on next-line therapy (PFS2) evaluated by investigators(An average of 3 year.)
- Adverse events (AEs)(An average of 3 year.)
- Serious adverse events (SAEs)(An average of 3 year.)
研究者
研究点 (2)
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