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

Barbara Ann Karmanos Cancer Institute

Status and phase: Terminated; Phase 1

Conditions: Breast Cancer

Treatments: Drug: DHEA; Procedure: Surgical resection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00972023

CDR0000653162

P30CA022453 (U.S. NIH Grant/Contract)

WSU-2008-012

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

DHEA, surgical resection

Experimental group

Description:

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;

Treatment:

Procedure: Surgical resection

Drug: DHEA