At a glance
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A Phase I Study of Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer
In Brief
A Phase 1 clinical trial evaluating Lapatinib, Whole Brain Radiation, and 1 other intervention for Breast Cancer and Brain Metastases. Completed, enrolled 35 participants across 3 sites.
Detailed Summary
The purpose of this research study is to determine the safety of combining lapatinib plus radiation in patients with breast cancer that has spread to the brain. Depending upon the participants cancer, they may also have stereotactic radiosurgery (SRS). Lapatinib s a compound that may stop cancer cells from growing abnormally. It is thought that lapatinib might also make cancer cells more sensitive to radiation. This drug has been used in other research studies in women with breast cancer, and information from those other research studies suggests that lapatinib may help to shrink or stabilize breast tumors both inside the brain and outside the brain.
Study Details
Timeline
Interventions
Orally twice daily
15 treatments over a period of 3 weeks
Herceptin 4mg/kg loading dose then 2 mg/kg IV once weekly, then once every three weeks after cycle 3.