DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: therapeutic dehydroepiandrosterone Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
- Tumor proliferation (percentage of Ki-67 positive cells) [ Designated as safety issue: No ]
- Effect of dehydroepiandrosterone (DHEA) on androgen receptor expression [ Designated as safety issue: No ]
- Effect of DHEA on changes in serum estrogen and androgen hormone levels (e.g., estrone, estradiol, testosterone, dihydrotestosterone, DHEA, and DHEA-sulfate) [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 25 |
| Study Start Date: | February 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Sinai-Grace Hospital | |
| Detroit, Michigan, United States, 48235 | |
| Principal Investigator: | Zeina Nahleh, MD | Barbara Ann Karmanos Cancer Institute |
| Investigator: | Amy Kranitz | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Zeina Nahleh, Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00972023 History of Changes |
| Other Study ID Numbers: | CDR0000653162, WSU-2008-012 |
| Study First Received: | September 3, 2009 |
| Last Updated: | August 25, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013