Eribulin plus pyrotinib In trastuzumab-resistant HER2-positive advanced breast cancer: A single-arm, multicenter phase II trial (EPIC trial).

• DOI: 10.1200/jco.2025.43.16_suppl.1031
• Publication Date: 2025-05-28T17:31:48Z
• Authors: Zhenchuan Song; Ruoyang Li
• Keywords: Eribulin

1031 Background: This study (ChiCTR2000038832) aimed to evaluate the efficacy and safety of combining eribulin with pyrotinib in patients advanced HER2-positive breast cancer who had developed resistance trastuzumab. These typically face a poor clinical prognosis, evidence-based guidance for treatment decisions remains limited. Methods: Eligible were those pathologically confirmed metastatic cancer, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, prior trastuzumab taxanes. Participants received oral (400 mg once daily) intravenous (1.4 mg/m² on days 1 8 each 21-day cycle) up six cycles. Pyrotinib was continued until disease progression intolerable toxicity. The primary endpoint progression-free survival (PFS). secondary endpoints include objective response rate (ORR), control (DCR), duration (DoR), overall (OS), safety. Results: Between February 2021 September 2023, 30 enrolled, median age 57 years (range: 30–76). All taxane therapies. As November 30, 2024, follow-up 20.1 months. Disease death occurred 15 patients, PFS 13.73 months (95% confidence interval [CI]: 11.1–14.8). 12-month 61.7% CI: 44.2%–86.0%). OS 75.3% 66.2%–84.4%). (ORR) 53.3% (16/30), (DCR) 80.0% (24/30). Median not reached. Common adverse events (AEs) any grade occurring > 15% included diarrhea (40%), nausea (20%), anorexia (16%), vomiting 3 reported 3% patients. No treatment-related deaths observed. Conclusions: combination shows promise as therapeutic option resistant While advancements anti-HER2 therapies continue, further studies are needed address unresolved challenges this context. Clinical trial information: ChiCTR2000038832 .