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Clinical Trial Title

Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer

Trial Status

Closed to Enrollment

Start Date

March 4, 2017

Trial Type

Cancer - Adult Oncology

Specific Condition

Brain Metastasis from HER2 Breast Cancer


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.

Eligibility Criteria

  • HER2 overexpressing breast cancer with at least 1 measurable and no more than 10 unirradiated parenchymal brain metastasis within 21 days prior to study entry
  • Newly diagnosed, multiple brain mets
  • or Progressive brain mets after stereotactic radiosurgery (SRS) or surgical resection of 1-3 mets
  • Karnofsky performance status ≥ 60 within 21 days prior to study entry
  • Age ≥ 18

Conditions for Ineligibility

  • Prior whole brain radiotherapy (WBRT)
  • Prior radiotherapy (any site) with concurrent lapatinib defined as 1 or more days
  • Prior invasive malignancy (except non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma, and invasive and non-invasive cancers related to the breast cancer) unless disease free for a minimum of 3 years
  • Leptomeningeal disease
  • Prior radiotherapy to the region of the study cancer except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion


Group 1: You will undergo WBRT for 5 days a week for 3 weeks for a total of 15 treatments, or SRS for 1 treatment.

Group 2: You will undergo WBRT or SRS as in group 1. You will also receive lapatinib ditosylate for 6 weeks.

IRB Number

Legacy IRB

Principal Investigator Name

Andrew Kee, MD

Contact Name

Oncology Clinical Research



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Last Updated: Wednesday, January 27, 2021 12:56:50 PM