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

OHSU Knight Cancer Institute

Status and phase: Terminated; Phase 1

Conditions: Breast Cancer

Treatments: Drug: DHEA; Other: pharmacological study; Drug: letrozole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00516542

OHSU-e2109

SOL-06019-L

P30CA069533 (U.S. NIH Grant/Contract)

OHSU-IRB00002109

R21CA119598 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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®])

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)