Breast Cancer Clinical Trial
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
Summary
Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed invasive breast cancer
Stage IIIB, IIIC with T4 lesion or Stage IV disease
Breast cancer must be ER-positive and/or PR-positive
Age ³ 18 years of age
ECOG performance status 0, 1 or 2
Able to swallow and oral medication
Adequate end organ function
Written informed consent
Exclusion Criteria:
Prior hormonal therapy for metastatic disease
Prior chemotherapy for metastatic disease
Prior treatment with sorafenib
Brain metastases or leptomeningeal disease
Evidence or history of bleeding
Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
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There are 4 Locations for this study
Washington District of Columbia, 20007, United States
Atlanta Georgia, 30322, United States
New Brunswick New Jersey, 08901, United States
Voorhees New Jersey, 08690, United States
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