Spots Global Cancer Trial Database for TKIs vs. Pertuzumab in HER2+ Breast Cancer Patients With Active Brain Metastases (HER2BRAIN)
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Trial Identification
Brief Title: TKIs vs. Pertuzumab in HER2+ Breast Cancer Patients With Active Brain Metastases (HER2BRAIN)
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
Study ID: NCT04760431
Study Description
Brief 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.
Detailed 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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Peking University International Hospital, Beijing, Beijing, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
First Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China
Contact Details
Name: Xuexin He, MD
Affiliation: Second Affiliated Hospital, Zhejiang University, School of Medicine
Role: PRINCIPAL_INVESTIGATOR
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