RTOG-1119

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

Principal Investigator

In Ah Kim

Status

Disease Site

Breast [BR] Breast

Phase

II

Developmental Therapeutics

No

Primary Objective

To determine if there is a signal for an increase in complete response (CR) rate in the measurable brain metastases at 12 weeks post RT (whole brain or SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.

Protocol and Other Documents:

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website

Data Collection Notice:

Data for this trial is being collected via the NRG/RTOG Data Center.

Patient Population

Pathologically (histologically or cytologically) proven diagnosis of invasive HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by FISH or SISH ≥ 2.0). At least one measurable, unirradiated parenchymal brain lesion.

Target Accrual

143