Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer

Conditions
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Breast Cancer, Breast Neoplasms

Intervention / Treatment
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* Drug: celecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>pre-operative placebo twice daily for two to three weeks | Drug: Placebo<br>* pre-operative placebo twice daily for two to three weeks<br>|
| Experimental: celecoxib<br>pre-operative celecoxib (400 mg) twice daily for two to three weeks | Drug: celecoxib<br>* pre-operative celecoxib (400 mg) twice daily for two to three weeks<br>* Other names: celebrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole-genome expression after celecoxib treatment | Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celecoxib, Clinical trial, Phase II, Oligonucleotide Array Sequence Analysis