Safety and Efficacy of Toripalimab in HER2- Metastatic Breast Cancer Patients Treated With Metronomic Vinorelbine

Metastatic Breast Cancer Clinical Trial

Official title: Safety and Efficacy of Metronomic Vinorelbine in Combination With Toripalimab for Patients With HER2- Metastatic Breast Cancer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Both study drugs will continue to be administered as long as patient experience clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

• NCT number: NCT04389073
• Study type: Interventional
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Fei Ma
• Phone: 86-10-87788060
• Email: drmafei@126.com
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2020
• Completion date: December 31, 2023