Clinical trial · Interventional
Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer
NCT00070057CI-TRIAL-00025281completedPhase 1ClinicalTrials.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)
This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (celecoxib)
- description
- Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
- interventionNames
- Drug: celecoxib
- Procedure: therapeutic conventional surgery
- Other: pharmacological study
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II (high-dose celecoxib)
- description
- Patients receive a higher dose of oral celecoxib as in arm I.
- interventionNames
- Drug: celecoxib
- Procedure: therapeutic conventional surgery
- Other: pharmacological study
- Other: laboratory biomarker analysis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive breast carcinoma * Tumor at least 1 cm by radiologic estimate or physical exam * No disease limited to ductal carcinoma in situ only * Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center * Hormone receptor status: * Not specified * Female * Postmenopausal as defined by at least 1 of the following: * No menstrual period within the past 12 months * Prior bilateral oophorectomy * No known liver disease * No renal insufficiency * No congestive heart failure * No coronary artery disease * No history of documented peptic ulcer disease * No gastritis * No medical condition that would preclude definitive surgery * No allergy to NSAIDs or sulfa-containing drugs * No connective tissue diseases, including any of the following: * Systemic lupus erythematosus * Reynaud's disease * Scleroderma * More than 3 months since prior chemotherapy * More than 2 weeks since prior hormone replacement therapy * More than 2 weeks since prior tamoxifen * More than 2 weeks since prior aromatase inhibitors * More than 2 weeks since prior raloxifene * More than 2 weeks since prior steroids * More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs) * More than 1 week since prior cyclooxygenase (COX)-2 inhibitors * No concurrent warfarin * No concurrent thiazide or loop diuretics * No concurrent COX-2 inhibitors * No concurrent NSAIDs
References
Publications (0)
Data not yet available
No reference posted for this study.