drugset / Trial / NCT06217185

The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

NCT06217185

Phase 4 Recruiting 100 enrolled Hebei Medical University Fourth Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes. Taxanes will be used for 6-8 cycles or discontinued due to intolerable Adverse Events (AEs), after which Capecitabine will be used for rhythmic chemotherapy combined with Pyrotinib + Trastuzumab. The aim is to explore the efficacy and safety of Pyrotinib, Trastuzumab, and Taxanes in treating Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).

Timeline

Start
2024-01-02
Primary completion
2025-12-11
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule 400 mg Oral
Subject Trastuzumab Monoclonal antibody 6 mg/kg
Background Capecitabine Small molecule 650 mg/m2