NCT06771609

Phase II Clinical Trial of PD-L1 in Combination with Vinorelbine + Cyclophosphamide + Capecitabine (VEX) Metronomic Chemotherapy with or Without Radiotherapy for Advanced Triple-negative Breast Cancer.

Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined with VEX Metronomic Chemotherapy with or Without Radiotherapy in Advanced Triple-negative Breast Cancer: a Prospective, Multicenter, Randomized Controlled Phase II Clinical Trial.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II clinical trial of PD-L1 in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.

Conditions

• Advanced Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Adebry single antibody + VEX metronomic chemotherapy + radiotherapy	1、Adebry antibody: 1200mg on day 1, every 3 weeks； 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W
DRUG	debry single antibody + VEX metronomic chemotherapy	1、Adebry antibody: 1200mg on day 1, every 3 weeks； 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W

Timeline

• Start date: 2024-09-10
• Primary completion: 2028-09-10
• Completion: 2028-09-10
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

2 sites across 1 country: China