dhea in treating women undergoing surgery for stage i, stage ii, or stage iii breast cancer

Conditions: Breast Cancer

Summary: 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.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed invasive adenocarcinoma of the breast * stage i (t1c), ii, or iii disease (ajcc staging system) * lesion ≥ 1 cm on breast imaging studies (mammogram, ultrasound, or mri) * her2/neu-negative tumor * planning to receive dehydroepiandrosterone (dhea) prior to surgery * disease amenable to surgery with curative intent * scheduled to undergo surgery immediately after completion of dhea * no locally advanced or metastatic disease not amenable to surgery * hormone receptor status: * estrogen receptor- and progesterone receptor-negative tumor * androgen receptor-positive tumor patient characteristics: * menopausal status not specified * ecog performance status (ps) 0-2 or karnofsky ps 60-100% * anc ≥ 1,000/mm\^3 * platelet count ≥ 75,000/mm\^3 * ast and alt ≤ 2.5 times upper limit of normal (uln) * alkaline phosphatase ≤ 2.5 times uln * bilirubin ≤ 2 times uln * hemoglobin \> 9 g/dl * creatinine normal or creatinine clearance ≥ 60 ml/min * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for ≥ 1 week after completion of study therapy * no history of allergic reactions attributed to compounds of similar chemical or biological composition to dhea or anastrozole * no concurrent uncontrolled illness, including but not limited to, any of the following: * ongoing or active infection * symptomatic congestive heart failure * unstable angina pectoris * cardiac arrhythmia * psychiatric illness or social situation that would limit compliance with study requirements prior concurrent therapy: * see disease characteristics * more than 5 years since prior surgery, radiotherapy, biological therapy, hormone therapy, and/or chemotherapy for invasive breast cancer * no other concurrent antineoplastic or antitumor agents * no other concurrent investigational agents

Keywords: triple-negative breast cancer stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer