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

Overview

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.

Full Title of Study: “A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2009

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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®])

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • OHSU Knight Cancer Institute
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rodney F. Pommier, MD, Study Chair, Oregon Health and Science University

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