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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DHEA
Surgical resection
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring triple-negative breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DHEA, surgical resection

Arm 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;

Outcomes

Primary Outcome Measures

Tumor Proliferation (Percentage of Ki-67 Positive Cells)

Secondary Outcome Measures

Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression
Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)
Toxicity

Full Information

First Posted
September 3, 2009
Last Updated
September 6, 2019
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00972023
Brief Title
DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
Official Title
A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
August 22, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
triple-negative breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHEA, surgical resection
Arm Type
Experimental
Arm 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;
Intervention Type
Drug
Intervention Name(s)
DHEA
Other Intervention Name(s)
therapeutic dehydroepiandrosterone
Intervention Description
DHEA administration will begin approxiately 14 days prior to surgery.
Intervention Type
Procedure
Intervention Name(s)
Surgical resection
Intervention Description
Surgical procedure of the invasive breast cancer
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
Toxicity
Time Frame
Within 48 hours prior to surgery and after 14 days of DHEA treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeina Nahleh, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.gov/clinicaltrials
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

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

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