Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
- 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.
- Determine the time to disease progression and overall survival of patients treated with
- 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
Antoinette R. Tan, MD
Cancer Institute of New Jersey
United States: Federal Government
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|