Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer

Completed · Phase 1

Conditions studied: Breast Cancer, Brain Metastases

In brief

The purpose of this research study is to determine the safety of combining lapatinib plus radiation in patients with breast cancer that has spread to the brain. Depending upon the participants cancer, they may also have stereotactic radiosurgery (SRS). Lapatinib s a compound that may stop cancer cells from growing abnormally. It is thought that lapatinib might also make cancer cells more sensitive to radiation. This drug has been used in other research studies in women with breast cancer, and information from those other research studies suggests that lapatinib may help to shrink or stabilize breast tumors both inside the brain and outside the brain.

Key facts

Study ID

NCT00470847

Run by

Nancy Lin, MD

People needed

35

Starts

2007-04-01

Expected to finish

2012-06-01

Last updated by the study team

2014-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically-confirmed invasive breast cancer
• HER2 overexpressing breast cancer defined as 3+ staining by immunohistochemistry, or HER2 gene amplification by FISH
• At least one parenchymal brain metastasis
• Disease progression in the CNS as assessed by at least one of the following; new neurological signs or symptoms; new lesion(s) in the CNS on an imaging study; progressive lesions on an imaging study
• At least two weeks since prior radiotherapy, last chemotherapy, immunotherapy, biologic therapy, or major surgery for cancer
• 18 years of age or older
• Life expectancy of greater than 12 weeks
• ECOG performance status 0-2
• Normal organ and marrow function as described in the protocol
• Left ventricular ejection fraction > 50%
• Able to swallow and retain oral medications

You may not qualify if…

• Prior WBRT
• Receiving any other investigational agents
• Concurrent chemotherapy, immunotherapy, biologic therapy or hormonal therapy for treatment of their cancer
• History of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to herceptin or lapatinib
• Leptomeningeal carcinomatosis as the only site of CNS involvement
• Concurrent treatment with medications that are either inducers of inhibitors of CYP3A4
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or active ulcerative colitis
• History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents
• Other known contraindication to MRI
• Uncontrolled intercurrent illness
• History of other active malignancy except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
• Pregnant or breastfeeding women

Where it is running

• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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