DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
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ClinicalTrials.gov Identifier: NCT00972023 |
Recruitment Status
:
Terminated
First Posted
: September 4, 2009
Results First Posted
: July 10, 2013
Last Update Posted
: March 21, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: DHEA Procedure: Surgical resection | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
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;
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Drug: DHEA
DHEA administration will begin approxiately 14 days prior to surgery.
Other Name: therapeutic dehydroepiandrosterone
Procedure: Surgical resection
Surgical procedure of the invasive breast cancer
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- 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. ]
- 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. ]
- 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. ]
- Toxicity [ Time Frame: Within 48 hours prior to surgery and after 14 days of DHEA treatment. ]

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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically or cytologically confirmed invasive adenocarcinoma of the breast
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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
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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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Responsible Party: | Barbara Ann Karmanos Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00972023 History of Changes |
Other Study ID Numbers: |
CDR0000653162 P30CA022453 ( U.S. NIH Grant/Contract ) WSU-2008-012 |
First Posted: | September 4, 2009 Key Record Dates |
Results First Posted: | July 10, 2013 |
Last Update Posted: | March 21, 2017 |
Last Verified: | February 2017 |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
triple-negative breast cancer stage I breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Dehydroepiandrosterone Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |