A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer
- To identify the effect of the adrenal steroid, dehydroepiandrosterone (DHEA), on tumor
proliferation in women with estrogen receptor-negative, progesterone receptor-negative,
HER2/neu-negative, and androgen receptor (AR)-positive stage I-III adenocarcinoma of
- To study the effect of DHEA on expression of AR in these patients.
- To assess the effect of DHEA on changes in serum estrogen and androgen hormone levels
(e.g., estrone, estradiol, testosterone, dihydrotestosterone, DHEA, and DHEA-sulfate)
in these patients.
- To assess the toxicity of DHEA in these patients.
- To follow the clinical course of these patients.
OUTLINE: Patients receive oral dehydroepiandrosterone (DHEA) twice daily on days -14 to 0.
Patients then undergo surgery on day 1.
Tissue samples are collected at baseline and at the time of surgery for biomarker analysis
(androgen receptor, estrogen receptor, progesterone receptor, HER2/neu, Ki-67, and p53) by
IHC. Blood samples are collected at baseline and after completion of treatment with DHEA for
analysis of serum hormone (e.g., estrone, estradiol, testosterone, dihydrotestosterone,
DHEA, and DHEA-sulfate) and cytokine levels.
After completion of study therapy, patients are followed up at 1 week and then every 6
months for 3 years.
Masking: Open Label, Primary Purpose: Treatment
Tumor proliferation (percentage of Ki-67 positive cells)
Zeina Nahleh, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|Sinai-Grace Hospital||Detroit, Michigan 48235|