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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

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. Secondary Objectives: To evaluate CR rate of the measurable brain metastases at 4 weeks post RT (WBRT/ SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate objective response rate of measurable brain metastases at 4 and 12 weeks post RT (WBRT/SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate targeted lesion-specific objective response rate (CR + PR) at 4 and 12 weeks post WBRT/SRS. To evaluate CNS progressive disease outside the targeted measurable disease with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate targeted lesion-specific progression at 4 and 12 weeks post WBRT/SRS To evaluate treatment related adverse events when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate Overall CNS complete response: Disappearance of all CNS target lesions sustained for at least 4 weeks; with no new lesions, no use of corticosteroids, and patient is stable or improved clinically, when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate overall CNS progressive disease (within or outside targeted measurable disease) with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate overall survival when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone.

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. Secondary Objectives: To evaluate CR rate of the measurable brain metastases at 4 weeks post RT (WBRT/ SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate objective response rate of measurable brain metastases at 4 and 12 weeks post RT (WBRT/SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate targeted lesion-specific objective response rate (CR + PR) at 4 and 12 weeks post WBRT/SRS. To evaluate CNS progressive disease outside the targeted measurable disease with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate targeted lesion-specific progression at 4 and 12 weeks post WBRT/SRS To evaluate treatment related adverse events when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate Overall CNS complete response: Disappearance of all CNS target lesions sustained for at least 4 weeks; with no new lesions, no use of corticosteroids, and patient is stable or improved clinically, when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate overall CNS progressive disease (within or outside targeted measurable disease) with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone. To evaluate overall survival when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone.