Breast Cancer Clinical Trial
Official title:
A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer
RATIONALE: Dehydroepiandrosterone (DHEA) may slow the growth of tumor cells and be an
effective treatment for women with breast cancer.
PURPOSE: This phase I trial is studying how well DHEA works in treating women undergoing
surgery for stage I, stage II, or stage III breast cancer.
OBJECTIVES:
Primary
- 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 the
breast.
Secondary
- 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.
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