Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00516542
- Lead Sponsor
- OHSU Knight Cancer Institute
- Brief Summary
RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA together with letrozole may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given together with letrozole in treating patients with metastatic breast cancer.
- Detailed Description
OBJECTIVES:
* To determine the maximum tolerable dose, dose-limiting toxicity, and pharmacokinetics of dehydroepiandrosterone (DHEA) when given together with letrozole in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer.
OUTLINE: Patients receive oral dehydroepiandrosterone and oral letrozole once daily. Physical exams and blood collections are performed every two weeks. Tumor assessments are performed once every three months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity One year from drug start Subjects will be monitored at day 14 and then every 2 weeks for up to one year.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Knight Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States