Breast Cancer Clinical Trial
DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III 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.
Full 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.
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
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There is 1 Location for this study
Detroit Michigan, 48201, United States
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