drugset / Trial / NCT04158947
A Study of HER2+ Breast Cancer Patients With Active Brain Metastases Treated With Afatinib & T-DM1 vs. T-DM1 Alone
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is being done for the following reasons: The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of Afatinib that can be given safely with T-DM1. The purpose of the second part of the study (Phase II) is to find out whether the dose of Afatinib with T-DM1 determined in Phase I will keep breast cancer from getting worse for a period of time.
Timeline
- Start
- 2020-05-10
- Primary completion
- 2023-12-31
- Completion
- 2024-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | 20 mg | Oral |
| Subject | Afatinib | Small molecule | 30 mg | Oral |
| Subject | Afatinib | Small molecule | 40 mg | Oral |
| Subject | Afatinib | Small molecule | 50 mg | Oral |
| Subject | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |