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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00972023
• Other study ID #: CDR0000653162
• Secondary ID: P30CA022453WSU-2
• Status: Terminated
• Phase: Phase 1
• Start date: February 2010
• Est. completion date: August 22, 2010

Study information

• Verified date: September 2019
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 22, 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• DHEA
DHEA administration will begin approxiately 14 days prior to surgery.

Procedure:
• Surgical resection
Surgical procedure of the invasive breast cancer

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Proliferation (Percentage of Ki-67 Positive Cells)		Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Secondary	Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression		Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Secondary	Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)		Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Secondary	Toxicity		Within 48 hours prior to surgery and after 14 days of DHEA treatment.

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database