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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Hupperets, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01695226
First received: September 25, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]

Other Outcome Measures:
  • Measurement of protein expression of CD34 and CASP3 in post-treated (celecoxib and placebo) breast cancer tissues [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695226

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

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pierre Hupperets, Dr., Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01695226     History of Changes
Other Study ID Numbers: MUMC MEC 04-038
Study First Received: September 25, 2012
Last Updated: September 25, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014