A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.
Triple-Negative Breast Cancer
About this trial
This is an interventional treatment trial for Triple-Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 ≥2. People with high blood pressure; A history of unstable angina; New diagnosis of angina pectoris. Myocardial infarction incident ;
Sites / Locations
- Fudan University Shanghai Cancer Center Shanghai, China, 200032Recruiting
Arms of the Study
Arm 1
Experimental
Camrelizumab plus Famitinib with/without nab-palitaxel