Status:
TERMINATED
DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
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 ...
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, H...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00972023
Start Date
February 1 2010
End Date
August 22 2010
Last Update
September 17 2019
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379