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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:
National Cancer Institute (NCI)
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
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: letrozole
Drug: DHEA
Other: pharmacological study
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • 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.


Enrollment: 6
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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®])
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516542

Locations
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)
Investigators
Study Chair: Rodney F. Pommier, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00516542     History of Changes
Other Study ID Numbers: SOL-06019-L, R21CA119598, P30CA069533, OHSU-e2109, OHSU-IRB00002109
Study First Received: August 14, 2007
Last Updated: July 23, 2012
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Breast Diseases
Skin Diseases
Dehydroepiandrosterone
Letrozole
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013