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A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer

Phase 1
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer



- 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.


- 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.

Inclusion Criteria


- 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


- 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

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor proliferation (percentage of Ki-67 positive cells)

Safety Issue:


Principal Investigator

Zeina Nahleh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

February 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • triple-negative breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms



Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Sinai-Grace HospitalDetroit, Michigan  48235