DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: DHEA; Surgical resection
Intervention description: DHEA administration will begin approxiately 14 days prior to surgery.; Surgical procedure of the invasive breast cancer
Intervention MeSH terms: Dehydroepiandrosterone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: triple-negative breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC 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.
    

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