- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00972023
DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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;
|
DHEA administration will begin approxiately 14 days prior to surgery.
Other Names:
Surgical procedure of the invasive breast cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
|
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.
|
Within 48 hours prior to surgery and after 14 days of DHEA treatment.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Zeina Nahleh, MD, Barbara Ann Karmanos Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000653162
- P30CA022453 (U.S. NIH Grant/Contract)
- WSU-2008-012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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