Breast Cancer Clinical Trial
Official title:
Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
letrozole may fight breast cancer by lowering the amount of estrogen the body makes.
Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill
more tumor cells.
PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating
postmenopausal women with locally advanced or metastatic breast cancer.
OBJECTIVES:
Primary
- Determine the response rate in postmenopausal women with hormone receptor-positive
locally advanced or metastatic adenocarcinoma of the breast treated with letrozole and
celecoxib as first-line therapy.
Secondary
- Determine the time to disease progression and overall survival of patients treated with
this regimen.
- Determine the toxicity of this regimen in these patients.
- Compare cyclooxygenase activity in blood and tumor cells from these patients before and
after treatment with this regimen.
- Determine the effect of this regimen on aromatase activity, tumor proliferation, and
angiogenesis in tumor samples from these patients.
OUTLINE: This is a multicenter study.
Patients receive oral letrozole once daily and oral celecoxib twice daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 45-72 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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