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

Information source: Maastricht University Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms; Breast Cancer

Intervention: celecoxib (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pierre Hupperets

Official(s) and/or principal investigator(s):
Pierre SJ Hupperets, MD; PhD, Principal Investigator, Affiliation: Maastricht University Medical Centre

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: whole-genome expression after celecoxib treatment

Secondary outcome: Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues

Eligibility

Minimum age: 18 Years. Maximum age: 74 Years. Gender(s): Female.

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

Locations and Contacts

University Hospital Maastricht, Maastricht, Limburg 6229 HX, Netherlands
Additional Information

Starting date: February 2004
Last updated: September 25, 2012

Page last updated: August 20, 2015

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