A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

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 ;