Clinical trial · Interventional
S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women
Randomized Placebo-Controlled Biomarker Modulation Trial Using Celecoxib in Premenopausal Women at High Risk for Breast Cancer
NCT00088972CI-TRIAL-00034290terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed due to poor accrual.
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer. PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I - Celecoxib
- description
- Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
- interventionNames
- Drug: celecoxib
- type
- PLACEBO_COMPARATOR
- label
- Arm II - Placebo
- description
- Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Mammographic Density
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.