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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00516542
Recruitment Status : Terminated (Study was terminated due to lack of accrual)
First Posted : August 15, 2007
Last Update Posted : July 24, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: letrozole Drug: DHEA Other: pharmacological study Phase 1

Detailed Description:


  • 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  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer
Study Start Date : June 2007
Primary Completion Date : July 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole
U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of breast cancer

    • Metastatic disease
  • Hormone receptor status

    • Estrogen receptor- and progesterone receptor-negative
    • Androgen receptor-positive


  • 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


  • 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®])

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00516542

United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Study Chair: Rodney F. Pommier, MD Oregon Health and Science University

Responsible Party: OHSU Knight Cancer Institute Identifier: NCT00516542     History of Changes
Other Study ID Numbers: SOL-06019-L
R21CA119598 ( U.S. NIH Grant/Contract )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by OHSU Knight Cancer Institute:
stage IV breast cancer
recurrent breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors