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

Sponsor
Jiangxi Provincial Cancer Hospital
Study ID
NCT04481763
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Triple-Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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。

Key Dates

Start date
Jul 14, 2020
Status verified
Jul 2020
Primary completion
Aug 30, 2024
Completion
Oct 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: camrelizumab + radiotherapy
    This is a open-labeled, single-arm, Investigator-initiated clinical trial ,Compared with historical data

Primary Outcome Measure

Invasive disease-free survival (iDFS) [ Time Frame: 3 years ]

Central Contacts

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