NCT04903652

Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer

A Prospective Phase Ⅱ Clinical Study of Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer That Has Failed Trastuzumab Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, single-arm, prospective phase II clinical study, which mainly evaluates the efficacy and safety of pyrotinib maleate combined with oral vinorelbine in the treatment of HER2-positive advanced breast cancer.

Detailed description

The most important treatment for HER2-positive breast cancer is based on anti-HER2 targeted therapy, combined with chemotherapy or endocrine therapy. China's original new anti-HER2 targeted therapy drug, pyrotinib, has obtained rapid approval from the country for its outstanding phase II clinical trial efficacy. In patients enrolled in the phase II trial, pyrotinib has a significant effect, but the combination of pyrotinib and capecitabine significantly increases the adverse reactions of diarrhea. For this reason, there is a lack of research on other combination schemes of pyrotinib in HER2 advanced breast cancer. In the first-line treatment, the combination therapy (HN) of trastuzumab and vinorelbine has shown that it also has a synergistic effect with vinorelbine in anti-HER2 targeted therapy. It provides a good evidence-based basis for the trial design of pyrotinib combined with vinorelbine soft capsules. This phase II clinical study is specially designed for preliminary exploration.

Conditions

• HER2-positive Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib Maleate	Pyrotinib p.o. 400 mg once daily
DRUG	Vinorelbine	Vinorelbine p.o. 40 mg once every other day

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-02-01
• Completion: 2022-02-06
• First posted: 2021-05-26
• Last updated: 2022-04-07

Locations

1 site across 1 country: China