Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00101062|
Recruitment Status : Terminated (study drug unavailable)
First Posted : January 10, 2005
Last Update Posted : June 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: celecoxib Drug: letrozole||Phase 2|
- 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101062
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Study Chair:||Antoinette R. Tan, MD||Rutgers Cancer Institute of New Jersey|