Intervention: Celecoxib
Trial phase: Phase 2
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Eligibility criteria:
DISEASE CHARACTERISTICS:

At elevated risk of developing breast cancer, as defined by 1 of the following:

Modified Gail risk at 5 years ≥ 1.7% or lifetime risk ≥ 20% AND Claus Model, BRCAPro Model, or Tyrer-Cuzick Model lifetime risk ≥ 20%
Diagnosis of lobular carcinoma in situ or ductal carcinoma in situ
Known deleterious mutation of BRCA1 or BRCA2
At least 1 breast available for imagery and biopsy

Has undergone a baseline mammogram with a standard density wedge within 7-14 days after completion of the last menstrual period AND within 7 days before study entry

Mammogram normal or benign (BIRADS score 0 or 1)

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Female

Menopausal status

Premenopausal, defined by 1 of the following criteria:

Last menstrual period < 6 months ago AND no prior bilateral ovariectomy AND not on estrogen replacement therapy
Prior hysterectomy (with ovaries still in place) AND normal follicle-stimulating hormone levels within 28 days of study entry

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Bilirubin < 2.0 times institutional upper limit of normal (IULN)
SGOT or SGPT < 2 times IULN
Alkaline phosphatase < 2 times IULN
INR ≤ 1.5
PT and PTT ≤ IULN

Renal

Serum creatinine < 2.0 times IULN

Cardiovascular

No history of myocardial infarction
No angina pectoris
No known coronary artery disease
No history of stroke or mini-stroke (e.g., transient ischemic attack)
No history of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)
No uncontrolled hypertension (i.e., blood pressure > 140/90 mmHg)

Pulmonary

No asthma after taking aspirin or other NSAIDs

Other

No known sensitivity to celecoxib
No allergy to sulfonamides
No urticaria or allergic-type reactions after taking aspirin or other NSAIDs
No extreme lactose intolerance
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or early bladder cancer (preinvasive transitional cell carcinoma of the bladder)
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 5 years since prior biologic therapy for cancer

Chemotherapy

More than 5 years since prior chemotherapy for cancer

Endocrine therapy

At least 28 days since prior tamoxifen
No prior systemic estrogen modifiers (SERMs) or aromatase inhibitors
Concurrent hormonal contraception (i.e., pills, patches, or shots) allowed provided contraception was initiated prior to study entry

Radiotherapy

No prior radiotherapy to the breast to be studied

Surgery

Not specified

Other

At least 7 days since prior anticoagulant therapy

More than 1 month since prior chronic daily aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) of more than 7 days duration

Concurrent intermittent aspirin or NSAIDs allowed (no more than 10 days per month)
No concurrent participation in another clinical trial for treatment or prevention of cancer unless no longer receiving treatment and is in the follow-up phase