- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01695226
Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229 HX
- University Hospital Maastricht
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
pre-operative placebo twice daily for two to three weeks
|
pre-operative placebo twice daily for two to three weeks
|
Experimental: celecoxib
pre-operative celecoxib (400 mg) twice daily for two to three weeks
|
pre-operative celecoxib (400 mg) twice daily for two to three weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
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 |
---|
Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues
|
Other Outcome Measures
Outcome Measure |
---|
Measurement of protein expression of CD34 and CASP3 in post-treated (celecoxib and placebo) breast cancer tissues
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pierre SJ Hupperets, MD; PhD, Maastricht University Medical Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- MUMC MEC 04-038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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