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

This study has been terminated.
(Study was terminated due to lack of accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00516542
First received: August 14, 2007
Last updated: July 23, 2012
Last verified: July 2012

August 14, 2007
July 23, 2012
June 2007
July 2009   (final data collection date for primary outcome measure)
Dose-limiting toxicity [ Time Frame: One year from drug start ] [ Designated as safety issue: Yes ]
Subjects will be monitored at day 14 and then every 2 weeks for up to one year.
  • Dose-limiting toxicity
  • Maximum tolerable dose
  • Pharmacokinetics
Complete list of historical versions of study NCT00516542 on ClinicalTrials.gov 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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
December 2010
July 2009   (final data collection date for primary outcome measure)

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®])
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00516542
SOL-06019-L, R21CA119598, P30CA069533, OHSU-e2109, OHSU-IRB00002109
Yes
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