At a glance
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A Phase II Trial of HKI-272 (Neratinib), Neratinib and Capecitabine, and Ado-Trastuzumab Emtansine for Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer and Brain Metastases
In Brief
A Phase 2 clinical trial evaluating HKI-272, Surgical Resection, and 2 other interventions for Breast Cancer. Completed, enrolled 140 participants across 18 sites.
Detailed Summary
The purpose of this research study is to determine how well neratinib works in treating breast cancer that has spread to the brain. Neratinib is a recently discovered oral drug that may stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2). In this research study, the investigators are looking to see how well neratinib works to decrease the size of or stabilize breast cancer that has spread to the brain. The investigators are also looking at how previous treatments have affected your thinking (or cognition) and how much neratinib reaches the central nervous system.
Study Details
Timeline
Interventions
240 mg orally, once daily
Neratinib concentrations from craniotomy specimen, CSF, plasma Neratinib.
750 mg/m2 orally, twice daily (1,500 mg/m2 daily) for 14 days followed by 7 days off
160 mg orally, once daily
3.6 mg/kg IV every 3 weeks