Real life safety, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer: a French ambispective multicentre 2 year-follow-up cohort study

Study identification

• EU PAS number:
  EUPAS1000000341
• Study ID:
  1000000341
• Official title and acronym:
  Real life safety, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer: a French ambispective multicentre 2 year-follow-up cohort study
• DARWIN EU® study:
  No
• Study countries:
  France
• Study status:
  Ongoing

Research institutions and networks

Institutions

Daiichi-Sankyo Europe GmbH

Germany

Euraxi Pharma

Study timelines

Date when funding contract was signed

Planned:28/10/2021

Actual:28/10/2021

Study start date

Planned:31/03/2021

Actual:14/12/2021

Date of interim report, if expected

Actual:08/02/2024

Date of final study report

Planned:30/09/2024

Sources of funding

Pharmaceutical company and other private sector 

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

NCT05149014