Clinical trial · Interventional
Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
- 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)
Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor celecoxib. In a single-centre double-blinded phase II study, breast cancer patients were randomised to receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray, which allows to study the genome-wide changes at the transcriptional level.
Conditions
Conditions (2)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- pre-operative placebo twice daily for two to three weeks
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- celecoxib
- description
- pre-operative celecoxib (400 mg) twice daily for two to three weeks
- interventionNames
- Drug: celecoxib
Primary outcomes (1)
- measure
- whole-genome expression after celecoxib treatment
- description
- Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients suspected of having invasive breast cancer, \>1 cm in diameter, and in whom there is an indication for a core or incision biopsy * Age \<75 years at time of diagnosis * Patient willing and able to comply with the study prescriptions * Patient able to give written informed consent before patient registration/randomisation * Pre- and post-menopausal patients are eligible * Hormone receptor positive and negative patients are eligible * A negative pregnancy test in pre-menopausal women Exclusion Criteria: * HIV, HBV or HCV positivity * Known hypersensitivity to NSAIDs * A history of upper gastro-intestinal bleeding * Endoscopically proven upper gastro-intestinal ulceration * Patients using NSAIDs, including salicyclic acid * Systemic use of corticosteroids * A history or the presence of any other malignancy excepting adequately treated squamous cell skin cancer or in situ carcinoma of the cervix * Patients who have been treated with neo-adjuvant chemotherapy or hormone therapy
References
Publications (1)
- RESULTBrandao RD, Veeck J, Van de Vijver KK, Lindsey P, de Vries B, van Elssen CH, Blok MJ, Keymeulen K, Ayoubi T, Smeets HJ, Tjan-Heijnen VC, Hupperets PS. A randomised controlled phase II trial of pre-operative celecoxib treatment reveals anti-tumour transcriptional response in primary breast cancer. Breast Cancer Res. 2013 Apr 8;15(2):R29. doi: 10.1186/bcr3409. PMID 23566419