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

NCT00516542 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-07-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Rodney F. Pommier, MD · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-07-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00516542 on ClinicalTrials.gov