Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.
- Conditions
- Triple-Negative Breast Cancer
- Interventions
- Registration Number
- NCT05760378
- Lead Sponsor
- Fudan University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 223
- 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
- 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 .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Famitinib Famitinib in Combination With Camrelizumab and TPC A nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin Famitinib in Combination With Camrelizumab and TPC B Camrelizumab Combination With Camrelizumab and TPC B nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin Combination With Camrelizumab and TPC A Camrelizumab Famitinib in Combination With Camrelizumab and TPC
- Primary Outcome Measures
Name Time Method PFS 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)
- Secondary Outcome Measures
Name Time Method ORR max 6 months The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
DoR max 6 months Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
CBR max 6 months The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
OS approximately 3 years time to death due to any cause
Trial Locations
- Locations (1)
Breast cancer institute of Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China