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DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer

2014-08-27 03:19:31 | BioPortfolio

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.

Description

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

therapeutic dehydroepiandrosterone, immunohistochemistry staining method, laboratory biomarker analysis, neoadjuvant therapy, therapeutic conventional surgery

Location

Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
United States
48201-1379

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:31-0400

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