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 (BOUDICA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37830
• EU PAS number:
  EUPAS9076
• Study ID:
  37830
• Official title and acronym:
  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 (BOUDICA)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  In July 2012, Afinitor in combination with exemestane was approved for the treatment of postmenopausal women with ER+, HER2- ABC after progression on a non-steroidal aromatase inhibitor and has become an option in United Kingdom (UK) clinical practice. UK audit data and anecdotal evidence to date has suggested a higher incidence of adverse events (AEs) than expected from the reported safety profile in the BOLERO-2 trial. The primary objective of this observational study is to describe, in patients commencing treatment with Afinitor in combination with exemestane two specific toxicities, namely stomatitis and non- infectious pneumonitis (NIP) in terms of: • incidence, severity, length of time to onset, duration and clinical course, • specific management (prophylaxis and intervention), • any potential predisposing factors
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Multiple centres: 25 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/05/2014

Actual: 01/05/2014

Study start date

Planned: 01/04/2015

Actual: 14/04/2015

Data analysis start date

Planned: 01/12/2015

Actual: 01/08/2016

Date of final study report

Planned: 01/03/2017

Actual: 01/08/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharmaceuticals

Study protocol

Initial protocol

crad001jgb14--protocol-v4.0-12Oct2015_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

CRAD001JGB14