Work

Neoadjuvant chidamide combined with chemotherapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (MUKDEN 05): a multicentre, single-arm, phase 2 trial

Year: 2025

Type: article

Abstract: 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/m 2 ) and cyclophosphamide (600 mg/m 2 ) administered every three weeks, followed by four cycles of docetaxel (100 mg/m 2 ) 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.

Source: The Lancet Regional Health - Western Pacific

DOI: 10.1016/j.lanwpc.2025.101700