• Maximum tolerable dose [ Designated as safety issue: No ]
  
• Dose-limiting toxicity [ Designated as safety issue: Yes ]
  
• Pharmacokinetics [ Designated as safety issue: No ]
  

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.

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®])