Breast Cancer Treatment with Afinitor® (Everolimus) and Exemestane for HR+ Women (BRAWO)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27127
• EU PAS number:
  EUPAS9462
• Study ID:
  27127
• Official title and acronym:
  Breast Cancer Treatment with Afinitor® (Everolimus) and Exemestane for HR+ Women (BRAWO)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  BRAWO is a German, non-interventional study with a planned enrollment of 3,000 patients with HR+ advanced breast cancer receiving Everolimus+Exemestane according to the approved label.Main objectives of the BRAWO study are to extend knowledge in the following areas• Efficacy and the impact of physical activity on efficacy and quality of life in routine clinical care• Prophylaxis and management of stomatitis• Sequence of therapy and drug utilization when EVE+EXE is used in routine clinical care
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Multiple centres: 400 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 20/06/2012

Actual: 20/06/2012

Study start date

Planned: 01/10/2012

Actual: 12/10/2012

Data analysis start date

Planned: 08/06/2017

Actual: 29/12/2017

Date of interim report, if expected

Planned: 08/06/2015

Date of final study report

Planned: 31/12/2018

Actual: 16/11/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Study protocol

Initial protocol

Protocol_final_BRAWO_CRAD001JDE53_Amendment 6 20151011_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

CRAD001JDE53