Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.
The present observational study aims to collect data on long-term safety of trastuzumab deruxtecan, with a primary endpoint on trastuzumab deruxtecan related adverse drug reactions (ADRs) of interest. Data on patient profile, treatment history (before, during and after trastuzumab deruxtecan administration), effectiveness and health-related quality of life will also be collected in a real-life setting, to confirm and complement data from clinical trials. Patients will be recruited whether they have started trastuzumab deruxtecan treatment or will start it at the time of inclusion, whether they were prescribed compassionate trastuzumab deruxtecan or marketed Enhertu®, in order to rapidly collect a large set of data.
Study Type
OBSERVATIONAL
Enrollment
306
Clinique des Flandres
Coudekerque-Branche, France
Percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
The primary endpoint is the percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
Time frame: 2 years following the start of administration of Trastuzumab deruxtecan
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.