Clinical trial · Interventional
Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
A Study to Identify Biomarker Modulation by a Cyclooxygenase-2 (COX-2) Inhibitor in Breast Tissue of Premenopausal Women at High Risk for Estrogen Receptor Negative (ERN) Breast Cancer
NCT00056082CI-TRIAL-00025985completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Celecoxib 400 mg bid
- description
- Celecoxib 400 mg bid
- interventionNames
- Drug: celecoxib
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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 allowedReferences
Publications (0)
Data not yet available
No reference posted for this study.