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

NCT ID: NCT00972023

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-08-22

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DHEA, surgical resection

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;

Group Type: EXPERIMENTAL

DHEA

Intervention Type: DRUG

DHEA administration will begin approxiately 14 days prior to surgery.

Surgical resection

Intervention Type: PROCEDURE

Surgical procedure of the invasive breast cancer

Interventions

DHEA

DHEA administration will begin approxiately 14 days prior to surgery.

Intervention Type: DRUG

Surgical resection

Surgical procedure of the invasive breast cancer

Intervention Type: PROCEDURE

Other Intervention Names

therapeutic dehydroepiandrosterone

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeina Nahleh, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Related Links

http://cancer.gov/clinicaltrials

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

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-2008-012

Identifier Type: -

Identifier Source: secondary_id

CDR0000653162

Identifier Type: -

Identifier Source: org_study_id