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

This study has been completed.
Information provided by (Responsible Party):
Pierre Hupperets, Maastricht University Medical Center Identifier:
First received: September 25, 2012
Last updated: NA
Last verified: September 2012
History: No changes 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.

Condition Intervention Phase
Breast Neoplasms
Breast Cancer
Drug: celecoxib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • whole-genome expression after celecoxib treatment
    Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues

Secondary Outcome Measures:
  • Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues

Other Outcome Measures:
  • Measurement of protein expression of CD34 and CASP3 in post-treated (celecoxib and placebo) breast cancer tissues

Study Start Date: February 2004
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
pre-operative placebo twice daily for two to three weeks
Drug: Placebo
pre-operative placebo twice daily for two to three weeks
Experimental: celecoxib
pre-operative celecoxib (400 mg) twice daily for two to three weeks
Drug: celecoxib
pre-operative celecoxib (400 mg) twice daily for two to three weeks
Other Name: celebrex


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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
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Please refer to this study by its identifier: NCT01695226

University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Pierre Hupperets
Principal Investigator: Pierre SJ Hupperets, MD; PhD Maastricht University Medical Centre
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pierre Hupperets, Dr., Maastricht University Medical Center Identifier: NCT01695226     History of Changes
Other Study ID Numbers: MUMC MEC 04-038
Study First Received: September 25, 2012
Last Updated: September 25, 2012

Keywords provided by Maastricht University Medical Center:
Clinical trial, Phase II
Oligonucleotide Array Sequence Analysis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on March 28, 2017