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.

A Multicentre, Open-parallel, Randomized, Controlled Phase Ⅲ Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer.

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).

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: 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 Criteria:

• 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