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.

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Apatinib; Paclitaxel

Criteria

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