ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00972023
Recruitment Status : Terminated
First Posted : September 4, 2009
Results First Posted : July 10, 2013
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: DHEA Procedure: Surgical resection Phase 1

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer
Study Start Date : February 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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;
 Drug: DHEA
DHEA administration will begin approxiately 14 days prior to surgery.
Other Name: therapeutic dehydroepiandrosterone

Procedure: Surgical resection
Surgical procedure of the invasive breast cancer


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Tumor Proliferation (Percentage of Ki-67 Positive Cells) [ Time Frame: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment. ]

Secondary Outcome Measures :
  1. Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression [ Time Frame: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment. ]
  2. Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate) [ Time Frame: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment. ]
  3. Toxicity [ Time Frame: Within 48 hours prior to surgery and after 14 days of DHEA treatment. ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972023


Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Zeina Nahleh, MD Barbara Ann Karmanos Cancer Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00972023     History of Changes
Other Study ID Numbers: CDR0000653162
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2008-012
First Posted: September 4, 2009    Key Record Dates
Results First Posted: July 10, 2013
Last Update Posted: March 21, 2017
Last Verified: February 2017

Keywords provided by Barbara Ann Karmanos Cancer Institute:
triple-negative breast cancer
stage I breast cancer
stage II breast cancer
 stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs