NCT04481763

A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jiangxi Provincial Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a open-labeled, single-arm, Investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with radiotherapy in patients with early triple-negative breast cancer. We will enroll 60 subjects. This study aims to evaluate the efficacy and safety of camrelizumab combined with radiotherapy in the treatment of early TNBC。

Detailed description

This trial is a prospective, multi-center, and exploratory clinical study, taking the Cancer Hospital of Jiangxi province as the lead unit, combined with breast cancer diagnosis and treatment norms, multi-center collaborative research to explore the iDFS of radiotherapy combined with carilizumab for triple-negative breast cancer of different subtypes and provide optimal personalized treatment options.

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab is 200 mg iv. administered every 2 weeks for 3 cycles with radiotherapy ( 50gy, 25 times for 5weeks)
RADIATION	radiotherapy	radiotherapy

Timeline

• Start date: 2020-07-14
• Primary completion: 2024-08-30
• Completion: 2026-10-01
• First posted: 2020-07-22
• Last updated: 2020-07-22

Locations

1 site across 1 country: China