NCT06254690

The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study

Safety and Efficacy of Pyrotinib in Transition From a Low-dose to Normal-dose Regimen in HER2-positive Advanced First-line Breast Cancer: a Multicenter, Open Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer

Detailed description

This study is planned to include 102 patients with HER2-positive advanced breast cancer meeting the admission criteria between 2023-12-01 and 2024-11-01. Statistical software will be used by the randomization officers for 1:1 allocation to pyrotinib dose increasing trial group and normal pyrotinib dose control group . The primary endpoint of this study was grade ≥3 treatment-emergent diarrhea incidence during the first 2 cycles according to Common Terminology Criteria for Adverse Events, version 5.0, and secondary endpoints were adverse effects of pyrotinib during the study, efficacy (progression-free survival and overall survival), and patient-reported outcome.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib dose escalation	Pyrotinib: 240mg in the first week, 320mg in the second week, and 400mg in the third week and thereafter, by mouth(po),once a day(qd) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2，intravenous(iv), every 3 weeks(q3w)
DRUG	Pyrotinib dose normal	Pyrotinib: 400mg per week, by mouth(po),once a day(qd) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2，intravenous(iv), every 3 weeks(q3w)

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2024-02-12
• Last updated: 2024-02-12

Locations

1 site across 1 country: China