NCT00516542

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

A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	letrozole	A daily dose of 2.5 mg will be used throughout the study.
DRUG	DHEA	Will be dispensed in either 500mg or 1000mg tablets. Subjects will start at a dose of 500 mg and may increase up to 5000mg depending on the cohort.
OTHER	pharmacological study	PK draws will happen on day 1 and day 14, then every 2 weeks.

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-07-01
• Completion: 2010-12-01
• First posted: 2007-08-15
• Last updated: 2012-07-24

Locations

1 site across 1 country: United States