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

July 23, 2012 updated by: OHSU Knight Cancer Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Knight Cancer Institute At Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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®])

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity
Time Frame: One year from drug start
Subjects will be monitored at day 14 and then every 2 weeks for up to one year.
One year from drug start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Rodney F. Pommier, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (Estimate)

August 15, 2007

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOL-06019-L
  • P30CA069533 (U.S. NIH Grant/Contract)
  • R21CA119598 (U.S. NIH Grant/Contract)
  • OHSU-e2109
  • OHSU-IRB00002109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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