Clinical trial · Interventional
A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and Lumpectomy/Mastectomy
Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer
NCT00328432CI-TRIAL-00001686completedPhase 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)
To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.
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 400 mg bid | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.
Secondary outcomes (1)
- measure
- Baseline and post-administration assessments of MAP kinase, pERK1 and 2, activated pAKT, change in apotosis indicators, and angiogenesis associated proteins, and Her-2/neu.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * women with a recent diagnosis of T1 or T2 non-invasive breast cancer by large core needle or excisional biopsy * confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post-diagnostic analyses to perform research assessments * reexcision planned within 10 days to 6 weeks from study start * if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision Exclusion Criteria: * no hormone replacement therapy within the 90 days prior to biopsy * if on prevention tamoxifen or raloxifene, must have begun administration at least six weeks prior to initial biopsy and continue through reexcision * no evidence of metastatic malignancy of any kind * no history of asthma, allergy ASA, NSAIDS, celecoxib or other COX-2 inhibitors for a chronic non-oncological condition with the excision of low dose ASA (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study. * no celecoxib or rofecoxib use within one month of biopsy * no history of gastrointestinal ulcer or ulcerative colitis requiring treatment * no current anticoagulants * no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study * no aromatase inhibitor in the six months prior to participation * no concomitant lithium * no known significant bleeding disorder
References
Publications (0)
Data not yet available
No reference posted for this study.