Clinical trial NCT01695226: Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
Official title: Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Breast Cancer
Keywords: Celecoxib
Clinical trial, Phase II
Oligonucleotide Array Sequence Analysis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-09-27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: whole-genome expression after celecoxib treatment
Secondary outcomes:
measure: Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues
Other outcomes:
measure: Measurement of protein expression of CD34 and CASP3 in post-treated (celecoxib and placebo) breast cancer tissues
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Pierre SJ Hupperets, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.