NCT01695226

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
Last Updated

January 9, 2018

Status Verified

September 1, 2012

Enrollment Period

3.4 years

First QC Date

September 25, 2012

Last Update Submit

January 5, 2018

Conditions

Breast NeoplasmsBreast Cancer

Keywords

CelecoxibClinical trial, Phase IIOligonucleotide Array Sequence Analysis

Outcome Measures

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

Study Arms (2)

placebo

PLACEBO COMPARATOR

pre-operative placebo twice daily for two to three weeks

Drug: Placebo

celecoxib

EXPERIMENTAL

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

Drug: celecoxib

Interventions

celecoxibDRUG

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

Also known as: celebrex
celecoxib
PlaceboDRUG

pre-operative placebo twice daily for two to three weeks

placebo

Eligibility Criteria

Age18 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

  • Brandao RD, Veeck J, Van de Vijver KK, Lindsey P, de Vries B, van Elssen CH, Blok MJ, Keymeulen K, Ayoubi T, Smeets HJ, Tjan-Heijnen VC, Hupperets PS. A randomised controlled phase II trial of pre-operative celecoxib treatment reveals anti-tumour transcriptional response in primary breast cancer. Breast Cancer Res. 2013 Apr 8;15(2):R29. doi: 10.1186/bcr3409.

    PMID: 23566419RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pierre SJ Hupperets, MD; PhD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2012

First Posted

September 27, 2012

Study Start

February 1, 2004

Primary Completion

July 1, 2007

Last Updated

January 9, 2018

Record last verified: 2012-09

Locations

NL(1)