NCT06217185

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HER2-positive Breast Cancer
• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib	Pyrotinib 400mg qd po continuously
DRUG	Trastuzumab	For Trastuzumab, the loading dose for the first treatment cycle is 8 mg/kg, and for subsequent cycles, 6 mg/kg. It is to be used once every three weeks
DRUG	Taxanes	Taxanes: Usual clinical dose is administered, in a 21-day cycle.
DRUG	Capecitabine	Capecitabine: 650mg/m2 each time, given twice daily

Timeline

• Start date: 2024-01-02
• Primary completion: 2025-12-11
• Completion: 2027-06-30
• First posted: 2024-01-22
• Last updated: 2024-02-28

Locations

1 site across 1 country: China