A Phase II Clinical Study of Sacituzumab Govitecan Combined With Bevacizumab for the Treatment of Patients With Metastatic Triple-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
研究概览
简要总结
This is a single-arm, multicenter, Phase II clinical study aiming to explore the efficacy and safety of Sacituzumab Govitecan combined with Bevacizumab as a second-line or later treatment for patients with metastatic triple-negative breast cancer (mTNBC). The study will be conducted in 6-8 centers in China.
The study is divided into two phases: a Safety Run-in Phase and a Dose Expansion Phase.
In the Safety Run-in Phase (3-12 patients), three dose levels are planned to determine the recommended dose. The starting dose (Level 1) is Sacituzumab Govitecan 10 mg/kg (Days 1, 8) plus Bevacizumab 7.5 mg/kg (Day 1) every 21 days. Based on the occurrence of Dose-Limiting Toxicities (DLT) in the first cycle, the Safety Monitoring Committee (SMC) will decide whether to continue the current dose or de-escalate to Level 2 (Sacituzumab Govitecan 10 mg/kg + Bevacizumab 5 mg/kg) or Level 3 (Sacituzumab Govitecan 7.5 mg/kg + Bevacizumab 5 mg/kg).
In the Dose Expansion Phase, 40-50 patients will be enrolled to receive the combination therapy at the recommended dose determined in the run-in phase. Efficacy will be evaluated every 2 cycles according to RECIST 1.1, and safety will be assessed continuously until disease progression or intolerable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients aged > 18 years.
- •Pathologically confirmed recurrent or metastatic Triple-Negative Breast Cancer (TNBC).
- •ER and PR negativity is defined as < 10% expression in tumor cells. HER2 negativity is defined as IHC 0, 1+, or IHC 2+ with FISH negative. Must have received at least one prior systemic therapy in the metastatic setting.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy of more than 3 months.
- •At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Adequate organ function.
- •Sufficient washout period before screening (3 weeks from last chemotherapy, 4 weeks from last targeted therapy)
排除标准
- •Prior treatment with Sacituzumab Govitecan or Bevacizumab.
- •Uncontrolled central nerve
- •Presence of other primary malignancies.
- •Severe infection, severe cardiac disease, autoimmune disease, or other conditions deemed unsuitable for anti-tumor therapy.
研究者
YING FAN
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences