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	Treatment or Intervention	Phase
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent breast cancer	Drug: celecoxib  Drug: letrozole  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: aromatase inhibition  Procedure: biological response modifier therapy  Procedure: endocrine therapy  Procedure: enzyme inhibitor therapy  Procedure: growth factor antagonist therapy  Procedure: hormone therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

New Jersey
      Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08903,  United States

Study chairs or principal investigators

Antoinette R. Tan, MD,  Study Chair,  Cancer Institute of New Jersey   

Study ID Numbers:  CDR0000407502; CINJ-NJ1103; CINJ-5076v3; CINJ-040402; UMDNJ-4761; NCT00101062
Record last reviewed:  February 2005
Last Updated:  February 9, 2005
Record first received:  January 7, 2005
ClinicalTrials.gov Identifier:  NCT00101062
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08