Breast Cancer, Breast Neoplasms
Conditions
Keywords
Celecoxib, Clinical trial, Phase II, Oligonucleotide Array Sequence Analysis
Brief summary
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.
Interventions
DRUGcelecoxib
pre-operative celecoxib (400 mg) twice daily for two to three weeks
DRUGPlacebo
pre-operative placebo twice daily for two to three weeks
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| whole-genome expression after celecoxib treatment | — | Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues |
Secondary
| Measure | Time frame |
|---|---|
| Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues | — |
Other
| Measure | Time frame |
|---|---|
| Measurement of protein expression of CD34 and CASP3 in post-treated (celecoxib and placebo) breast cancer tissues | — |
Countries
Netherlands
Outcome results
None listed