Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: celecoxib
* Drug: letrozole


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the breast Locally advanced or metastatic disease Measurable disease No bone disease only No history of brain metastases unless controlled with radiotherapy or surgical resection for ≥ 6 months before study entry Hormone receptor status: Estrogen receptor- OR progesterone receptor-positive PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Postmenopausal, as defined by 1 of the following: Prior bilateral oophorectomy Prior bilateral ovarian irradiation No spontaneous menstrual bleeding within the past 12 months Age 55 and over AND prior hysterectomy without oophorectomy Age 54 and under AND prior hysterectomy without oophorectomy (or status of ovaries is unknown) AND documented follicle-stimulating hormone level in postmenopausal range Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Granulocyte count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Other No prior allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs No prior allergic reaction to sulfonamides No active peptic ulcer disease No active infection No other medical condition that would preclude study participation Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic or recurrent disease Endocrine therapy No prior endocrine therapy for metastatic disease Prior adjuvant tamoxifen allowed No prior aromatase inhibitors No prior hormonal therapy for recurrent disease No other concurrent hormonal therapy Radiotherapy See Disease Characteristics See Menopausal status No concurrent radiotherapy Surgery See Disease Characteristics See Menopausal status Other No concurrent fluconazole or lithium No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other cyclooxygenase-2 inhibitors Concurrent chronic cardioprotective low-dose aspirin allowed No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Drug: letrozole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer