Status:
TERMINATED
A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Breast Cancer
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) in combination with Nab-paclitaxel and A...
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: locally advanced or metastatic breast cancer; Locally advanced breast cancer not amenable to radical resection.
- No prior systemic antitumor therapy for metastatic triple-negative breast cancer.
- Adequate hematologic and organ function
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Exclusion
- Known central nervous system (CNS) disease.
- Previously received anti-VEGFR small molecule tyrosine kinase inhibitors or anti-PD-1/PD-L1 antibody.
- A history of bleeding, any serious bleeding events.
- Uncontrolled pleural effusion, pericardial effusion.
- Malignancies other than TNBC within 5 years prior to randomisation, or ascites requiring recurrent drainage procedures
- History of interstitial pneumonitis.
- Severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB, etc.
- Prior allogeneic stem cell or solid organ transplantation.
- History of autoimmune disease
- Active hepatitis B or hepatitis C
- Pregnancy or lactation.
- Peripheral neuropathy grade ≥2.
- Participants with poor blood pressure control;
- Myocardial infarction incident within 6 months prior to randomisation;
- Treatment with systemic immunostimulatory agents within 4 weeks prior to randomisation
- Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04335006
Start Date
July 14 2020
End Date
April 14 2023
Last Update
May 6 2023
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China