NCT04639271

Pyrotinib, Trastuzumab And Abraxane in HER2-positive MBC With Brain Metastasis

A Single-arm, Open-label Study Of Pyrotinib Combined WithTrastuzumab And Abraxane in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.

Detailed description

Overexpression of HER2 is associated with increased incidence of brain metastases in breast cancer, accounting for about 20-50% of HER2 positive breast cancer. Treatment strategy ranged from local therapies to systemic anti-HER2 therapies, prognosis of patients with brain metastases remains poor. Previous clinical trials had demonstrated the efficacy of trastuzumab and TKIs for brain metastasis. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. We designed the study to explore the efficacy and safety of pyrotinib combined with trastuzumab and abraxane in HER2-positive MBC with brain metastasis.

Conditions

• Breast Cancer
• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib Plus And	Pyrotinib::400mg/d,qd,po
DRUG	Trastuzumab	8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle
DRUG	Abraxane	Abraxane 125mg/M2, qw iv

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-01-01
• Completion: 2022-03-01
• First posted: 2020-11-20
• Last updated: 2020-11-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study