TTC after T-DXd
Objectif(s) de la recherche et intérêt pour la santé publique
Objectifs poursuivis
Domaines médicaux investigués
Bénéfices attendus
To describe the progression-free survival of patients treated by TTC as a subsequent chemotherapy following T-DXd exposure defined as the time between initiation of the TTC treatment and the following progression or death. Patient not experiencing progression or death will be censored at the date of last follow-up.. To describe overall survival of patients treated TTC as a subsequent chemotherapy following T-DXd exposure defined as the time between initiation of the TTC treatment and the time of death. Patient. alive at the date of last follow-up will be censored.. . To describe time to brain metastasis progression for patients with brain metastasis at the initiation of TTC treatment. Time to brain metastasis progression is defined as the time interval between the date of initiation of TTC treatment and the date of documented progression of the brain metastasis.. Progression of brain metastasis will be evaluated according to RECIST v1.1, as determined by investigator assessment, as the appearance of a new lesion at the brain level, or as the reappearance of a lesion for patients who experienced complete response (CR) at the brain level.. Patients without brain metastasis progressionat the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment.. . To describe time to brain metastasis for patients without brain metastasis at the initiation of TTC treatment. Time to brain metastasis is defined as the time interval between the date of initiation of TTC treatment and the date of documented brain metastasis. Existence of brain metastasis will be evaluated according to RECIST v1.1, as determined by investigator assessment, or as the appearance of a lesion at the brain level. Patients who have not developed brain metastasis at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment.. . To describe the response rate at the brain level for patients having brain metastasis. Response rate will be evaluated retrospectively according to RECIST 1.1 and RANO criteria. Overall response rate (ORR), for patients with measurable disease as determined locally by investigator according to RECIST 1.1 criterion (resp. RANO criterion), is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 criterion (resp.RANO criterion).
Données utilisées
Catégories de données utilisées
Source de données utilisées
Variables sensibles utilisées
Calendrier du projet
Base légale pour accéder aux données
Durée de conservation aux fins du projet (en années)
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Fondement juridique
Article 6 du RGPD (Licéité du traitement)
Article 9 du RGPD (Exception permettant de traiter des données de santé)
Transfert de données personnelles vers un pays hors UE
Droits des personnes
Les droits des personnes, prévus aux articles 15 à 20 du RGPD (accès, rectification, effacement, limitation et portabilité), s’exercent auprès du DPO de l’établissement. Les personnes ont également la possibilité de s’opposer au traitement de leurs données, conformément à l’article 21 du RGPD. Les patients sont informés de leurs droits via le livret d’accueil, le site internet de l’établissement, par voie d’affichage dans les salles d’attente et par le consentement générique recherche.