A Multicenter, Randomized Trial of Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) Versus Adebrelimab Combined With TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of Triple-negative Breast Cancer
This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.
• Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;
• Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC \< 1%, PR negative: IHC \< 1%, HER2 negative: IHC 0/1 + or IHC2 + but ISH negative;
• Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;
• ECOG score 0-1;
• Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;
• Appropriate level of organ function
• Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.