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.
- Conditions
- Triple Negative Breast CancerBreast Cancer
- Interventions
- Registration Number
- NCT04335006
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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 Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 80
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental B Nab-paclitaxel Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle Comparator C Nab-paclitaxel Subjects receive nab-paclitaxel intravenously each 4-week cycle. Experimental A Nab-paclitaxel Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle Experimental A Carelizumab Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle Experimental A Apatinib Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle Experimental B Carelizumab Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months) Progression-free survival (PFS) as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in PD-L1 positive / ITT population
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) in PD-L1 positive/ITT population Up to approximately 42 months Progression Free Survival (PFS) Up to approximately 42 months Progression Free Survival (PFS) as determined by the investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in PD-L1 positive/ITT population
Objective response rate (ORR) in the PD-L1-positive/ITT population Up to approximately 42 months Percentage of Participants with Adverse Events (AEs) Up to approximately 42 months Serum concentration of SHR-1210 and plasma concentration of apatinib Up to approximately 42 months Proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline Up to approximately 42 months Clinical benefit rate (CBR), defined as the proportion of patients with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1 Up to approximately 42 months
Trial Locations
- Locations (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China