Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: Metastatic Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00634634
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 52
- Starts
- 2008-08-11
- Expected to finish
- 2023-04-28
- Last updated by the study team
- 2023-11-09
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Georgetown University Hospital — Washington D.C., District of Columbia, United States
- Emory University — Atlanta, Georgia, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Cooper Hospital/University Medical Center — Voorhees Township, New Jersey, United States
Full record on ClinicalTrials.gov
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