Triple-negative breast cancer (TNBC) presents significant challenges due to its limited treatment options and poor efficacy. While neoadjuvant chemotherapy has improved breast-conserving rates and extended survival for TNBC patients, this subtype still faces issues such as restricted treatment modalities, low pathological response rates, and unfavorable prognosis compared to other subtypes. Studies like Keynote522 and IMpassion031 have shown that combining chemotherapy with immunotherapy yields a pCR rate of 64.8% in early-stage high-risk TNBC patients, suggesting that such combinations can offer substantial benefits. However, the low immunogenicity of breast cancer and the lack of clear predictive molecular markers for effective immunotherapy result in suboptimal pCR and objective response rates for this group. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of stereotactic radiotherapy combined with PD-1 inhibitors and chemotherapy in the neoadjuvant treatment of TNBC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
318
Radiotherapy: 24Gy/3f, once every other day; Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle; Carboplatin AUC=5, IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
Chemotherapy: Cycles 1-4: Albumin-bound paclitaxel: 260 mg/m², IV, administered on day 1 of each cycle; Carboplatin AUC=5, IV, administered on day 1 of each cycle. Cycles 5-8: Epirubicin: 90-100 mg/m², IV, administered on day 1 of each cycle; Cyclophosphamide: 600 mg/m², IV, administered on day 1 of each cycle; Immunotherapy: PD-1 inhibitor, once every three weeks
West China Hospital, Sichuan University
Sichuan, Chengdu, China
RECRUITINGpCR
The percentage of patients showing no evidence of invasive cancer cells in the tissue samples after treatment
Time frame: The time immediately after the complete surgery
Breast conservation rate
The percentage of patients undergoing breast-conserving surgery
Time frame: 3 year
Ipsilateral breast recurrence or local regional recurrence
The percentage of patients experiencing a recurrence of cancer in the same breast or in the nearby lymph nodes
Time frame: 3 year
Overall survival
The period from the start of treatment until the occurrence of death.
Time frame: 3 year
The incidence of adverse events
The safety
Time frame: Up to approximately 1 year
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