Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00516542|
Recruitment Status : Terminated (Study was terminated due to lack of accrual)
First Posted : August 15, 2007
Last Update Posted : July 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: letrozole Drug: DHEA Other: pharmacological study||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer|
|Study Start Date :||June 2007|
|Primary Completion Date :||July 2009|
|Study Completion Date :||December 2010|
- Dose-limiting toxicity [ Time Frame: One year from drug start ]Subjects will be monitored at day 14 and then every 2 weeks for up to one year.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516542
|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|