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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01695226
• Other study ID #: MUMC MEC 04-038
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2012
• Last updated: January 5, 2018
• Start date: February 2004

Study information

• Verified date: September 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• celecoxib
pre-operative celecoxib (400 mg) twice daily for two to three weeks
• Placebo
pre-operative placebo twice daily for two to three weeks

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Brandão 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 transcri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of protein expression of CD34 and CASP3 in post-treated (celecoxib and placebo) breast cancer tissues
Primary	whole-genome expression after celecoxib treatment	Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues
Secondary	Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues