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

Phase 2Not Yet RecruitingNCT06691594

Cancer Institute and Hospital, Chinese Academy of Medical Sciences20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Invasive

Interventions

Eligible participants will receive neoadjuvant treatment consisting of: SBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor). Chemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5). Surgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response. Adjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Signed written informed consent prior to enrollment Age ≥ 18 years ECOG PS score 0-1 Newly diagnosed T1c N1-2 or T2-3 N0-2 breast cancer Triple-negative breast cancer with PD-L1 CPS \< 10 Hemoglobin ≥ 10.0 g/dl, neutrophils ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L BUN ≤ 1.5 × upper limit of normal (ULN), creatinine ≤ 1.5 × ULN Serum bilirubin ≤ 1.5 × ULN, alkaline phosphatase (AKP), AST, and ALT ≤ 2.5 × ULN Women of childbearing potential must be willing to use contraception during the study Negative serum or urine pregnancy test within 7 days prior to treatment Exclusion Criteria Occult breast cancer Bilateral breast cancer Breast tumor unsuitable for SBRT Unable to undergo MRI scanning History of other malignancies that may affect survival Active autoimmune disease or history of autoimmune disease Current use of immunosuppressants or systemic steroids (within 2 weeks prior to enrollment) Known allergy to any component of the investigational drugs Uncontrolled cardiac symptoms or diseases Active infection or unexplained fever \> 38.5°C during screening/before first dose Other factors likely to cause early study termination (e.g., serious concurrent illnesses, significant lab abnormalities, or social/family circumstances affecting safety/data collection)

Outcomes

Primary Outcomes

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

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

Time frame: From enrollment to the completion of surgery