ReferenceRRK2861

Neo-excel

Neoadjuvant trial of pre-operative exemestane or letrozole +/-celecoxib in the treatment of ER positive postmenopausal early breast cancer

Research Summary

This trial aims to utilise 2 different breast cancer treatment modalities which may complement each other.Several studies have reported an association between reduction of breast cancer risk in patients taking nonsteroidalanti-inflammatory drugs (NSAIDS). Celecoxib is a NSAID. Studies have shown that the COX (cyclooxygenase)2 enzyme isfound in high concentrations in cancers and may cause cancers to grow faster. Celecoxib inhibits COX 2 and this effect maydecrease cancer growth. Aromatase inhibitors (such as exemestane and letrozole) have become established as highlyeffective treatments for shrinking cancers prior to surgery. This effect may be enhanced by the addition of a COX 2 inhibitorbecause of the interaction between the aromatase and cyclooxygenase pathways.It is well documented that body image is as important in postmenopausal patients as in premenopausal patients. This trialwill provide clear information on whether the addition of the COX 2 inhibitor celecoxib to a third generation aromataseinhibitor increases the proportion of subjects achieving improved clinical and pathological response and local disease controlin postmenopausal women with ER positive breast cancer. It will also provide clear information as to whether a steroidal(exemestane) or non-steroidal (letrozole) aromatase inhibitor is more effective in this neoadjuvant setting. If the addition ofcelecoxib to an aromatase inhibitor as neoadjuvant treatment increases the response in down-staging the tumour thenbreast conserving surgery may for the first time be an option for a subset of patients previously assigned no choice butmastectomy. The cosmetic result of surgery may be improved in patients responding by allowing less extensive surgery.Information from this trial would have immense clinical implications for the treatment of postmenopausal oestrogen receptorpositive breast cancer.

Research Overview
PI Name Rea - DW
Speciality
Sponsor University of Birmingham
Project Status Open
Proposed End Date 01/05/2017
Study Run through CRF? No
Recruitment so far 26