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

August 14, 2007
August 15, 2007
July 24, 2012
June 2007
July 2009   (Final data collection date for primary outcome measure)
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.
  • Maximum tolerable dose
  • Dose-limiting toxicity
  • Pharmacokinetics
Complete list of historical versions of study NCT00516542 on Archive Site
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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

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.


  • 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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • 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.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
July 2009   (Final data collection date for primary outcome measure)


  • 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®])
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R21CA119598 ( U.S. NIH Grant/Contract )
P30CA069533 ( U.S. NIH Grant/Contract )
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OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Study Chair: Rodney F. Pommier, MD Oregon Health and Science University
OHSU Knight Cancer Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP