An Open, Randomized Phase III Study of Famitinib With Camrelizumab Plus Treatment of Physician's Choice (TPC) Versus Camrelizumab Plus TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic Triple-negative Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG Performance Status of 0-1
- •Expected lifetime of not less than three months
- •Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- •Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection.
- •Adequate hematologic and end-organ function, laboratory test results.
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) • Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer
排除标准
- •Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
- •A history of bleeding, any serious bleeding events.
- •Important blood vessels around tumors has been infringed and high risk of bleeding.
- •Coagulant function abnormality
- •artery/venous thromboembolism event
- •History of autoimmune disease
- •Positive test for human immunodeficiency virus
- •Active hepatitis B or hepatitis C
- •Uncontrolled pleural effusion and ascites • Known central nervous system (CNS) disease.
- •Long-term unhealing wound or incomplete healing of fracture
- •urine protein ≥2+ and 24h urine protein quantitative > 1 g.
- •Pregnancy or lactation.
- •Thyroid dysfunction.
- •Peripheral neuropathy grade ≥
- •People with high blood pressure;
- •A history of unstable angina;
- •New diagnosis of angina pectoris.
- •Myocardial infarction incident .
研究组 & 干预措施
A
Famitinib in Combination With Camrelizumab and TPC
干预措施: Famitinib (Drug)
A
Famitinib in Combination With Camrelizumab and TPC
干预措施: Camrelizumab (Drug)
A
Famitinib in Combination With Camrelizumab and TPC
干预措施: nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin (Drug)
B
Combination With Camrelizumab and TPC
干预措施: Camrelizumab (Drug)
B
Combination With Camrelizumab and TPC
干预措施: nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin (Drug)
结局指标
主要结局
PFS
时间窗: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years)
time to progressive disease (according to RECIST1.1)
次要结局
- ORR(max 6 months)
- DoR(max 6 months)
- CBR(max 6 months)
- OS(approximately 3 years)