A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Subjects will be monitored at day 14 and then every 2 weeks for up to one year.
One year from drug start
Rodney F. Pommier, MD
Oregon Health and Science University
United States: Food and Drug Administration
|Knight Cancer Institute at Oregon Health and Science University||Portland, Oregon 97239-3098|