Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations