|Principal Investigator/ Physician||Weisi Yan, MD|
|Protocol No.||RTOG 1119|
|Contact Email||MCI Clinical Trials|
Protocol Title: "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."
Inclusion Criteria: HER2 overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by FISH or SISH ≥ 2.0; at least 1 measurable, unirradiated parenchymal brain metastasis within 21 days prior to study entry; Karnofsky performance status ≥ 60 within 21 days prior to study entry
Exclusion Criteria: Prior WBRT; Prior RT with concurrent lapatinib defined as 1 or more days on which the patient received both radiation therapy and lapatinib on the same day; prior invasive malignancy (except for non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma and invasive and non-invasive cancers related to breast cancer) unless disease free for a minimum of 3 years; leptomeningeal disease; prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy
Clinical Trails.Gov Link: https://clinicaltrials.gov/ct2/show/NCT01622868?term=RTOG+1119&rank=1
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