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

Phase 1TerminatedNCT00516542

OHSU Knight Cancer Institute6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

letrozoleDRUG

A daily dose of 2.5 mg will be used throughout the study.

DHEADRUG

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.

pharmacological studyOTHER

PK draws will happen on day 1 and day 14, then every 2 weeks.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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 \[Herceptin®\])

Locations (1)

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Dose-limiting toxicity

Subjects will be monitored at day 14 and then every 2 weeks for up to one year.

Time frame: One year from drug start

Data from ClinicalTrials.gov

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