Observational prospective study in post-menopausal women with advanced HR+/HER2- breast cancer treated with a combination of Afinitor® + exemestane to describe the management of two Adverse Events, non-infectious lung disease and stomatitis (TANGO)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37868
• EU PAS number:
  EUPAS7325
• Study ID:
  37868
• Official title and acronym:
  Observational prospective study in post-menopausal women with advanced HR+/HER2- breast cancer treated with a combination of Afinitor® + exemestane to describe the management of two Adverse Events, non-infectious lung disease and stomatitis (TANGO)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This observational study aims to describe two specific AEs, non infectious lung disease and stomatitis, and their management in women with ER+/HER2- advanced breast cancer treated with Afinitor® + exemestane.Primary objective: To describe the patterns of management for stomatitis and non-infectious lung disease (therapeutic classes, specific management)
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Multiple centres: 150 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 08/08/2013

Actual: 08/08/2013

Study start date

Planned: 15/11/2014

Actual: 07/11/2014

Data analysis start date

Planned: 15/11/2015

Actual: 28/04/2017

Date of final study report

Planned: 30/11/2017

Actual: 21/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharmaceuticals

Study protocol

Initial protocol

RAD001JFR38_TANGO_Protocol_V4_Amendement -2015 07 21_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

CRAD001JFR38