Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing breast cancer in at-risk women.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing breast cancer in premenopausal women who are at risk of developing cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Kansas Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

Criteria

DISEASE CHARACTERISTICS:

• Increased risk for breast cancer on the basis of at least 1 of the following criteria:

• Five-year Gail risk at least 1.7% or a calculated risk at least 5 times the average for age group

• 20-29 years old - calculated 5-year Gail risk is at least 0.1%

• 30-39 years old - calculated 5-year Gail risk is at least 1.0%

• 40 and over - calculated 5-year Gail risk is at least 1.7%

• Known BRCA1/BRCA2 mutation carrier

• Family history consistent with hereditary breast cancer, as defined by any of the following circumstances:

• At least 4 relatives with breast cancer at any age

• At least 2 first-degree relatives diagnosed with breast cancer at age 50 or younger

• Breast and ovarian cancer diagnosed in the same relative

• At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer at any age in the same family

• Prior biopsy exhibiting atypical hyperplasia, lobular cancer in situ, ductal carcinoma in situ (DCIS)*, or invasive cancer** NOTE: *If DCIS or T1a or T1b disease was found, at least 2 months must have elapsed since prior surgery and/or radiotherapy to the involved breast

NOTE: **Prior invasive cancer (T1c, T2, or T3) must have been diagnosed at least 2 years before study and be estrogen receptor-negative, node negative

• Must have had a random periareolar fine needle aspiration successfully performed within the past 3 months, with at least 1,000 cells on cytology slide and 3 additional slides for biomarker analysis (1 with at least 500 cells for Ki-67 and 2 with at least 100 ductal cells for estrogen receptors and COX-2)

• Hormone receptor status:

• Estrogen receptor negative

PATIENT CHARACTERISTICS:

Age

• 18 to 55

Sex

• Female

Menopausal status

• Premenopausal, defined as menstrual periods estimated to occur every 21 to 35 days over the past 6 months

Performance status

• Not specified

Life expectancy

• At least 5 years

Hematopoietic

• Absolute granulocyte count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10 g/dL

• No bleeding diathesis within the past year

Hepatic

• Bilirubin no greater than 2.0 mg/dL

• Albumin at least 3.0 g/dL

• AST and ALT no greater than 2 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2 times ULN

• No severe liver disease requiring treatment

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• No high blood pressure not controlled by medication

• No history of angina

• No history of cardiovascular disease

• No history of deep vein thrombosis

Pulmonary

• No history of pulmonary embolism

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No prior allergy to sulfa, COX-2 inhibitors, or nonsteroidal anti-inflammatory drugs (NSAIDs)

• No history of an ulcer requiring treatment

• No history of ulcerative colitis

• No inflammatory bowel disease

• No body mass index > 33

• No history of diabetes

• No prior metastatic malignancy of any kind

• No complications of alcoholism requiring hospitalization

• No concurrent asthma being treated

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 6 months since prior chemotherapy

Endocrine therapy

• At least 6 months since prior antihormone therapy (e.g., selective estrogen-receptor modulators or aromatase inhibitors)

• Anticipated use of oral or IV corticosteroids must be less than 2 weeks per year

• No change (stop or start) in hormonal therapy within the past 6 months (e.g., estrogen, progesterone, oral contraceptives, or fertility agents)

Radiotherapy

• See Disease Characteristics

• No prior radiotherapy to the contralateral breast involved in the study treatment

Surgery

• See Disease Characteristics

Other

• At least 3 weeks since prior aspirin, rofecoxib, celecoxib, other COX-2 inhibitors, or NSAIDs

• No concurrent anticoagulants

• No other concurrent NSAIDs

• No chronic angiotensin-converting enzyme inhibitors

• No chronic furosemide*

• No chronic fluconazole*

• No chronic lithium NOTE: *Occasional concurrent use allowed