NCT04158947: A Study of HER2+ Breast Cancer Patients With Active Brain Metastases Treated With Afatinib & T-DM1 vs. T-DM1 Alone

Breast Cancer Type: HER2+
Hormone Mutations: ER+, PR+
Other Mutations: 
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 2
Drug Category: Therapeutic antibody, Tyrosine-Kinase inhibitor

Key Eligibility Criteria:

Gender: Female
Age: 18 Years to 75 Years (Adult, Older Adult)
Location of Metastases: Brain, Leptomeningeal Disease
Additional Notes: Patients must have at least 1 new and/or progressive brain metastases (greater than or equal to 10 mm) after completion of whole brain radiotherapy, stereotactic radiosurgery, or during or after a HER2 inhibitor-based therapy (e.g. (trastuzumab, lapatinib, pyrotinib, tucatinib
Exclusions: Patients with prior treatment of erlotinib and/or certain chemotherapies – see trial for details; Patients with only meningeal metastasis

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