Actively Recruiting
Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.
Led by Fudan University · Updated on 2024-02-06
223
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.
CONDITIONS
Official Title
Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- ECOG Performance Status of 0-1
- Expected lifetime of at least three months
- Histologically confirmed metastatic or locally advanced triple-negative breast cancer (TNBC) lacking HER2, ER, and PR expression
- Recurrent or metastatic breast cancer with local recurrence not amenable to radical surgery
- Adequate blood counts and organ function based on laboratory tests
- Measurable disease per RECIST v1.1 criteria
- No prior chemotherapy or targeted therapy for metastatic TNBC
You will not qualify if you...
- Previous treatment with anti-VEGFR small molecule tyrosine kinase inhibitors (e.g., famitinib, sorafenib, sunitinib, regorafenib)
- History of serious bleeding or bleeding disorders
- Tumors involving important blood vessels with high bleeding risk
- Abnormal blood clotting function
- History of artery or venous thromboembolism
- History of autoimmune disease
- Positive test for HIV
- Active hepatitis B or C infection
- Uncontrolled pleural effusion or ascites
- Known central nervous system (CNS) disease
- Long-term non-healing wounds or fractures
- Urine protein level ≥2+ or 24-hour urine protein >1 g
- Pregnancy or breastfeeding
- Thyroid dysfunction
- Peripheral neuropathy grade 2 or higher
- High blood pressure
- History of unstable angina or new angina diagnosis
- Recent myocardial infarction
AI-Screening
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Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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