At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed invasive breast cancer
- ✓HER2-overexpressing breast cancer by IHC 3+ or FISH/SISH ≥2.0
- ✓At least 1 measurable unirradiated parenchymal brain metastasis; SRS patients limited to ≤10 metastases, WBRT unlimited; solitary lesion ≥10 mm, ≥2 lesions with ≥2 at ≥5 mm
- ✓Able to swallow and retain oral medication (suspension formulation acceptable)
- ✕Prior whole-brain radiotherapy
- ✕Prior radiation therapy at any site concurrent with lapatinib (same-day exposure)
- ✕Leptomeningeal disease
- ✕Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric illness limiting compliance
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer - A Collaborative Study of NRG Oncology and KROG
In Brief
A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Lapatinib Ditosylate, and 2 other interventions for HER2-Positive Breast Carcinoma and 4 related conditions. Completed, enrolled 143 participants across 302 sites in 3 countries.
Detailed Summary
This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.
Study Details
Timeline
Interventions
Correlative studies
Given PO
Undergo SRS
Undergo WBRT