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

Phase 2

Completed

• Conditions: Breast Cancer; Breast Neoplasms
• Interventions: Drug: Placebo; Drug: celecoxib

• Registration Number: NCT01695226
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2007-07
• Status Verified: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-27
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	pre-operative placebo twice daily for two to three weeks
celecoxib	celecoxib	pre-operative celecoxib (400 mg) twice daily for two to three weeks

Primary Outcome Measures

Name	Time	Method
whole-genome expression after celecoxib treatment		Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues

Secondary Outcome Measures

Name	Time	Method
Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues

Trial Locations

Locations (1)

University Hospital Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands