Breast Cancer Clinical Trial
Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer
Summary
RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA together with letrozole may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given together with letrozole in treating patients with metastatic breast cancer.
Full Description
OBJECTIVES:
To determine the maximum tolerable dose, dose-limiting toxicity, and pharmacokinetics of dehydroepiandrosterone (DHEA) when given together with letrozole in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer.
OUTLINE: Patients receive oral dehydroepiandrosterone and oral letrozole once daily. Physical exams and blood collections are performed every two weeks. Tumor assessments are performed once every three months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Metastatic disease
Hormone receptor status
Estrogen receptor- and progesterone receptor-negative
Androgen receptor-positive
PATIENT CHARACTERISTICS:
ECOG performance status 0-3
Postmenopausal (> 60 years of age)
Leukocyte count > 3,000/uL
Absolute neutrophil count > 1,500/uL
Platelet count > 100,000/uL
Total bilirubin normal
AST and ALT < 2.5 times upper limit of normal
Creatinine normal OR creatinine clearance > 60 mL/min
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior chemotherapy
At least 4 weeks since prior biologic therapy
At least 4 weeks since prior radiotherapy
At least 30 days since prior investigational agents
No concurrent dehydroepiandrosterone or androstenedione supplements
No concurrent chemotherapy or radiotherapy
No concurrent hormone therapy or immunotherapy (including trastuzumab [Herceptin®])
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There is 1 Location for this study
Portland Oregon, 97239, United States
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