Status:
UNKNOWN
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)
Lead Sponsor:
Fudan University
Conditions:
Triple-Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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 immunomodula...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04129996
Start Date
October 1 2019
End Date
September 1 2022
Last Update
January 11 2022
Active Locations (1)
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1
Zhi-Ming Shao
Shanghai, China, 200032