نبذة مختصرة : Summary: Background: Existing neoadjuvant therapies for hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) breast cancer have not achieved optimal clinical outcomes, thus prompting the investigation of novel treatment strategies. Given the emerging significance of HDAC inhibitors in the management of advanced breast cancer, this study investigated the efficacy and safety of chidamide plus chemotherapy as neoadjuvant therapy for patients with HR+/HER2− breast cancer. Methods: This single arm, open-label, multicentre, phase 2 trial was conducted at three hospitals in China. Patients aged 18–75 years who had treatment-naïve, stage II–III HR+/HER2− breast cancer with an Eastern Cooperative Oncology Group performance status of 0–1 were enrolled. Patients received oral chidamide at a dose of 20 mg on days 1, 4, 8, and 11 of each 21-day cycle. The chemotherapy regimen consisted of four cycles of epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) administered every three weeks, followed by four cycles of docetaxel (100 mg/m2) administered every three weeks. The primary endpoint was the rate of residual cancer burden (RCB) 0–I. This study is registered with ClinicalTrials.gov, NCT05400993. Findings: Between May 23, 2022 and July 6, 2023, a total of 54 female patients (median age: 50 years [range, 26–75]) were recruited. The RCB 0–I rate was 35.2% (19 of 54, 95% confidence interval [CI], 22.7%–49.4%). The most frequent grade 3 or 4 adverse events were decreased neutrophil count (70%) and decreased white blood cell (67%). No treatment-related deaths occurred. Interpretation: The combination of chidamide and chemotherapy shows the potential to be an alternative neoadjuvant therapy option for patients with HR+/HER2− breast cancer. Funding: Shenyang Municipal Science and Technology Program (Grant No. 22-321-32-18), Shenzhen Chipscreen Biosciences Co., Ltd.
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