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)

Study Overview
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Brief Summary
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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..

Official Title
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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: An Open, Single-arm, Multicenter, Efficacy and Safety Phase II Clinical Study.

Conditions
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Triple-Negative Breast Cancer

Intervention / Treatment
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* Drug: camrelizumab in combination with nab-paclitaxel and famitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: camrelizumab in combination with nab-paclitaxel and famitinib<br> | Drug: camrelizumab in combination with nab-paclitaxel and famitinib<br>* camrelizumab in combination with nab-paclitaxel and famitinib for triple negative breast cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in all Participants | Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first |