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Clinical Trials/NCT06691594
NCT06691594
Not Yet Recruiting
Phase 2

Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Breast Cancer Invasive
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment
20
Primary Endpoint
the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.

Registry
clinicaltrials.gov
Start Date
February 2025
End Date
November 2030
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shulian Wang

Professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

Time Frame: From enrollment to the completion of surgery

pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment

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