drugset
drugset / Trial / NCT04760431

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

NCT04760431 ↗

Phase 2 Unknown 120 enrolled Second Affiliated Hospital, School of Medicine, Zhejiang University Peking University International Hospital · collabSun Yat-sen University · collabZhejiang University · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-10-01
Primary completion
2024-09-30
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Neratinib Small molecule 240 mg Oral
Comparator Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Pyrotinib Small molecule 400 mg Oral
Subject Tucatinib Small molecule 300 mg Oral
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Paclitaxel Small molecule 260 mg/m2 Intravenous
Background Paclitaxel liposome Unknown 135 mg/m2 Intravenous
Background Paclitaxel liposome Unknown 175 mg/m2 Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous

Indications

HER2 positive breast carcinoma metastatic malignant neoplasm in the brain