DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer

• Status: Terminated
• Trial end date: 2010-08-22
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dehydroepiandrosterone

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