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Completed

NCT Number: 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.

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Key information

Conditions

Breast Neoplasms Breast Cancer Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

pre-operative celecoxib (400 mg) twice daily for two to three weeks

Other names: celebrex

Placebo

Drug

pre-operative placebo twice daily for two to three weeks

Primary outcomes

  1. whole-genome expression after celecoxib treatment

    Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues

Secondary outcomes

  1. Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues

Other outcomes

  1. Measurement of protein expression of CD34 and CASP3 in post-treated (celecoxib and placebo) breast cancer tissues

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2004
Primary completion
2007
First posted
Sep 27, 2012
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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