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NCT05670925
A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.
Conditions: Triple-Negative Breast Cancer
Sex: Female
Ages: 18 Years – 70 Years
Phase: PHASE2
Enrollment: 46
Sponsor: Fudan University
Location: China
Summary
The study is being conducted to evaluate the Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib with/without Nab-paclitaxel, of Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.
Eligibility Criteria
Inclusion Criteria:ECOG Performance Status of 0-1Expected lifetime of not less than three monthsMetastatic 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 cancerExclusion 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 abnormalityartery/venous thromboembolism eventHistory of autoimmune diseasePositive test for human immunodeficiency virusActive hepatitis B or hepatitis CUncontrolled pleural effusion and ascites • Known central nervous system (CNS) disease.Long-term unhealing wound or incomplete healing of fractureurine 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 ;
Source: ClinicalTrials.gov (NCT05670925). StuddyBuddy aggregates publicly available trial information.