DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer|
- Tumor Proliferation (Percentage of Ki-67 Positive Cells) [ Time Frame: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment. ] [ Designated as safety issue: No ]
- Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression [ Time Frame: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment. ] [ Designated as safety issue: No ]
- Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate) [ Time Frame: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment. ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Within 48 hours prior to surgery and after 14 days of DHEA treatment. ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: DHEA, surgical resection
Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;
DHEA administration will begin approxiately 14 days prior to surgery.
Other Name: therapeutic dehydroepiandrosteroneProcedure: Surgical resection
Surgical procedure of the invasive 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 the breast.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972023
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Principal Investigator:||Zeina Nahleh, MD||Barbara Ann Karmanos Cancer Institute|