Mes données de santé
The information site for patients treated within the Unicancer network or included in Unicancer network clinical trials. 
Objectives

Objectif principal

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

Objectifs secondaires

a. 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.

b. 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.

c. 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.

d. 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).  

Data controller

Institut de cancérologie de l'Ouest

Categories of data used
Données d’identification (sans donnée nominative) / Données de santé
Origine de données utilisées
Soins
Institut de Cancérologie de l'Ouest (Nantes et Angers)
2018
2019
2020
2021
2022
Gustave Roussy (Villejuif)
2018
2019
2020
2021
2022
Centre Léon Bérard (Lyon)
2018
2019
2020
2021
2022
Centre Georges François Leclerc (Dijon)
2018
2019
2020
2021
2022
Institut Paoli Calmettes (Marseille)
2018
2019
2020
2021
2022
Centre Antoine Lacassagne (Nice)
2018
2019
2020
2021
2022
Centre Eugène Marquis (Rennes)
2018
2019
2020
2021
2022
Institut Bergonié (Bordeaux)
2018
2019
2020
2021
2022
Institut Curie (Paris et Saint-Cloud)
2018
2019
2020
2021
2022
Institut du Cancer de Montpellier
2018
2019
2020
2021
2022
Centre Oscar Lambret (Lille)
2018
2019
2020
2021
2022
Others (excluding cancer centers)
2018
2019
2020
2021
2022
Others (excluding cancer centers)
2018
2019
2020
2021
2022
Other
Autre établissement (hors CLCC) :Le CARIO (St Brieuc)
Autre établissement (hors CLCC) : IUTC Oncopole de Toulouse
Population subject to research or data processing

All patients (women) aged over 18 years previously treated with trastuzumab deruxtecan (T-DXd) for metastatic HER2+ breast cancer

Legal basis

Intérêt public

Internal and external data recipients

Institut de cancérologie de l'Ouest

Research start date
01/12/2022
Data retention period

Conservation pendant 2 ans après la valorisation (publication/article, thèse, présentation orale, poster, autre) des résultats de la recherche. Puis archivage avec un accès restreint aux personnes intervenant dans la recherche, pendant une durée limitée de 3 ans (5ans au total post publication)

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