Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer
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.
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer|
- Dose-limiting toxicity [ Time Frame: One year from drug start ] [ Designated as safety issue: Yes ]Subjects will be monitored at day 14 and then every 2 weeks for up to one year.
|Study Start Date:||June 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
- 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.
|United States, Oregon|
|Knight Cancer Institute at Oregon Health and Science University|
|Portland, Oregon, United States, 97239-3098|
|Study Chair:||Rodney F. Pommier, MD||Oregon Health and Science University|