Clinical Trials

Title   RTOG 1119
Principal Investigator/ Physician   Weisi Yan, MD
Protocol┬áNo.   RTOG 1119
Open Date   03/11/2014
Cancer Site   Breast
Status   Closed
Sponsor   RTOG
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

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