Trial reportDrug design, development and therapy2025
Eribulin plus Pyrotinib in Trastuzumab-Resistant, HER2-Positive Advanced Breast Cancer: A Single-Arm, Multicenter Phase II Trial (EPIC Trial).
Trial report in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
6 authors.
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Abstract
Purpose: This study aimed to assess the efficacy and safety of combining Eribulin with Pyrotinib in patients diagnosed with advanced HER2-positive breast cancer and exhibiting resistance to trastuzumab. This subgroup of patients typically faces a bleak clinical prognosis with limited guidance available for treatment decisions. Patients and Methods: Patients (N=30) with HER2-positive metastatic breast cancer, ECOG 0-1, and prior trastuzumab/taxane therapy received oral Pyrotinib 400 mg daily and intravenous Eribulin 1.4 mg/m² (days 1/8 of 21-day cycles for 6 cycles), followed by Pyrotinib until progression/intolerable toxicity. The primary endpoint was progression-free survival (PFS). Results: Between February 2021 and September 2023, 30 patients were enrolled in the study, with a median age of 57 years. All patients had previously received treatment with trastuzumab and taxanes. As of April 14, 2025, the median follow-up duration was 26 months. 18 patients experienced disease progression or death. The median progression-free survival (PFS) was 13.47 months (95% confidence interval [CI], 8.17-16.27), with a 12-month PFS rate of 61.7% (95% CI, 44.2%-86.0%). 12-month overall survival (OS) rate of 75.3% (95% CI 66.2-84.4). The objective response rate was 56.7% (17/30). The disease control rate (DCR) reached 80.0% (24/30), while the clinical benefit rate (CBR) was 73.3% (22/30). The median overall survival was not reached. Any adverse event (AE) of any grade with an incidence of more than 30% was Neutropenia (73.3%), diarrhea (70%), nausea/vomiting (66.7%), Peripheral neuropathy (63.3%), AST/ALT increased (43.3%), Anorexia (33.3%). There were no treatment-related deaths. Conclusion: The combination of Eribulin and Pyrotinib emerges as a viable treatment option for HER2-positive advanced breast cancer patients who have exhibited resistance to trastuzumab. Despite advancements in anti-HER2 therapies, further research is required to address remaining challenges in this specific clinical scenario.
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