Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dehydroepiandrosterone; Letrozole

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®])