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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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)
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Xuran Zhao, Doctor
Data sourced from clinicaltrials.gov
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