BOUDICA
Research type
Research Study
Full title
A phase IV multicentre, open-label, non-interventional study of postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer treated with Afinitor® (everolimus [RAD001]) in combination with exemestane, after progression following therapy with a non-steroidal aromatase inhibitor.
IRAS ID
166626
Contact name
Lisa Price
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
This is a phase IV multicentre, open-label, observational study of postmenopausal women with advanced breast cancer starting treatment on Afinitor® and exemestane.
The purpose of this observational study is to collect information about how Afinitor® in combination with exemestane is being used and the effect it has on the advanced breast cancer as well as any adverse effects, such as Stomatitis (this is a general term for an inflamed mouth, a very common adverse event following therapy with Afinitor® and exemestane) and Non-Infectious Pneumonitis (an inflammatory condition of the lung that is non-infectious and has been observed in patients taking Afinitor®). This observational study will also collect information on other treatment the patient may be given following the end of treatment with Afinitor® and exemestane.
A minimum of 200 patients from the United Kingdom will participate in this observational study across approximately 25 centres in the United Kingdom.This observational study does not impose any tests or assessments outside of the patients routine care. Patients will be treated according to local prescribing information for Afinitor® in combination with exemestane and thereafter at the discretion of the investigator. Patients will be asked to complete two health questionnaires.
REC name
London - Chelsea Research Ethics Committee
REC reference
14/LO/2231
Date of REC Opinion
29 Jan 2015
REC opinion
Further Information Favourable Opinion