A Multi-center, Open-label, Randomized, Phase II Trial of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel as First-line Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) that is PD-L1 positive.
Eligible patients will be randomized in a 1:1 ratio to receive either sacituzumab govitecan plus toripalimab or toripalimab plus nab-paclitaxel. Tumor response will be assessed by investigators according to RECIST v1.1 at baseline, every 6 weeks during the first year, and every 12 weeks thereafter.
The primary objective is to evaluate progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to response (TTR), and safety profile according to NCI-CTCAE v5.0.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥18 years.
- •Histologically or cytologically confirmed triple-negative breast cancer (TNBC).
- •Unresectable locally advanced or metastatic disease.
- •PD-L1 positive (CPS ≥1 as assessed by central laboratory).
- •No prior systemic treatment for advanced or metastatic TNBC.
- •Measurable disease per RECIST v1.
- •ECOG performance status of 0 or
- •Adequate hematologic, hepatic, and renal function.
- •Willingness to provide informed consent.
排除标准
- •Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
- •Known active central nervous system metastases.
- •Active autoimmune disease or history of autoimmune disorders requiring systemic treatment.
- •Active infection requiring systemic therapy.
- •Pregnancy or lactation.
- •Other active malignancies requiring treatment within the past 5 years.
- •History of severe hypersensitivity reactions to study drugs.
研究组 & 干预措施
SG plus Toripalimab
Participants will receive sacituzumab govitecan at 10 mg/kg via IV infusion on Days 1 and 8 of each 21-day cycle, and toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
干预措施: Sacituzumab Govitecan (SG) (Drug)
SG plus Toripalimab
Participants will receive sacituzumab govitecan at 10 mg/kg via IV infusion on Days 1 and 8 of each 21-day cycle, and toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
干预措施: Toripalimab (Drug)
Nab-Paclitaxel plus Toripalimab
Participants will receive toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle, and nab-paclitaxel at 125 mg/m² via IV infusion on Days 1 and 8 of each cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
干预措施: Toripalimab (Drug)
Nab-Paclitaxel plus Toripalimab
Participants will receive toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle, and nab-paclitaxel at 125 mg/m² via IV infusion on Days 1 and 8 of each cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From randomization until disease progression or death, assessed up to 36 months
Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as assessed by investigators based on RECIST version 1.1 criteria.
次要结局
- Duration of Response (DOR)(From first response until progression or death, assessed up to 36 months)
- Time to Response (TTR)(From randomization to first response, assessed up to 36 months)
- Incidence of Adverse Events and Serious Adverse Events(From first dose until 30 days after last dose)
- Overall Survival (OS)(From randomization until death, assessed up to 48 months)
- Objective Response Rate (ORR)(From first dose to first confirmed response, assessed up to 36 months)