Safety and Efficacy of Toripalimab in HER2- Metastatic Breast Cancer Patients Treated With Metronomic Vinorelbine
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
The investigators hypothesize that the administration of Toripalimab (anti-PD-1 antibody,
JS001) combined to metronomic Vinorelbine may be an interesting therapeutic option for female
patients with HER2- metastatic breast cancer. The approach suggested here is to deplete and
active the immune response of these patients. The combination of Toripalimab and Vinorelbine
would provide a higher gain in anti-tumor response in these patients than in those with
chemotherapy alone.
The investigators proposal is to conduct a multicentric, single arm, Phase II trial in HER2-
patients with metastatic breast cancer, aiming to evaluate the clinical activity of the
combination therapy Toripalimab + metronomic Vinorelbine. Patients will receive Vinorelbine
(40 mg/day, tiw, per os) and Toripalimab (240 mg every 3 weeks, intravenously [IV]). The
adverse events of the two drugs are well known.
Phase:
Phase 2
Details
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences