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A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer


Phase 1
60 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

A Phase I Study of DHEA in Combination With Letrozole in ER- 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.

Inclusion 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®])

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity

Outcome Description:

Subjects will be monitored at day 14 and then every 2 weeks for up to one year.

Outcome Time Frame:

One year from drug start

Safety Issue:

Yes

Principal Investigator

Rodney F. Pommier, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Food and Drug Administration

Study ID:

SOL-06019-L

NCT ID:

NCT00516542

Start Date:

June 2007

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • male breast cancer
  • Breast Neoplasms

Name

Location

Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098