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TKIs vs. Pertuzumab in HER2+ Breast Cancer Patients With Active Brain Metastases (HER2BRAIN)

Brain Metastases Clinical Trial

Official title:
Anti-HER2 TKI Versus Pertuzumab in Combination With Dose-dense Trastuzumab and Taxane as First Line in HER2-positive Breast Cancer Patients With Active Brain Metastases: A Phase II, Multicenter, Double-blind, Randomized Clinical Trial

Clinical Trial Summary

This is a prospective, randomized, 2-arm, Phrase 2, superiority and multicenter study to compare the efficiency of Anti-HER2 TKI versus Pertuzumab in Combination With Dose-dense Trastuzumab and Taxane in HER2-positive breast cancer patients with active refractory brain metastases.

Clinical Trial Description

This is a prospective, randomized, 2-arm, Phrase 2, superiority and multicenter study. HER2-positive breast cancer patients with active refractory brain metastases are included. There will be two group: Group A (Trastuzumab, Taxanes and Pertuzumab) and Group B (Trastuzumab, Taxanes and TKIs). The primary outcome is objective response rate (ORR). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04760431
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Xuexin He, MD
Phone 18329139569
Email xuexinhe@zju.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date October 1, 2021
Completion date September 30, 2025
View Details
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