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REALITY 01

Sécurité, effet et qualité de vie de trastuzumab déruxtécan en conditions de vie réelle, chez des patients souffrant de cancer du sein métastatique ou non résécable HER2+ : étude française ambispective multicentrique à 2 ans de suivi

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.

Current primary outcome:
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 ]

Critères d'inclusion :

- Male or female adult patient (age ≥ 18 years);


- Unresectable or metastatic HER2+ breast cancer, previously treated with at least 2 lines of anti-HER2, and:


*previously treated by compassionate trastuzumab deruxtecan (ATU group), or


*previously treated or planned to be treated by trastuzumab deruxtecan (Enhertu®), upon the investigator's decision (Post-Marketing authorization group);


- Patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive.

Critères de non inclusion :

- Previous participation in an interventional clinical trial with trastuzumab deruxtecan