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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT00972023

Recruitment Status:

Terminated

Sponsor:

Barbara Ann Karmanos Cancer Institute

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There is 1 Location for this study

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Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States

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Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT00972023

Recruitment Status:

Terminated

Sponsor:


Barbara Ann Karmanos Cancer Institute

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