A Trial of Camrelizumab in Combination With Nab-paclitaxel and Famitinib as a First Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer(FUTURE-C-PLUS)

• Status: Recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study is being conducted to evaluate the efficacy, safety of camrelizumab in combination with nab-paclitaxel and famitinib in Patients with unresectable locally advanced or metastatic immunomodulatory triple negative breast Cancer..

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

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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 ;

• Arrhythmia for long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency