LORHA - A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients Still Alive
Responsable(s) :
Roche Medical Data Center
Date de modification : 30/06/2022 | Version : 1 | ID : 74136
| Général | |
| Identification | |
| Nom détaillé | A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients Still Alive |
| Sigle ou acronyme | LORHA |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | ML23001 |
| Thématiques générales | |
| Domaine médical |
Cancer research |
| Etude en lien avec la Covid-19 |
No |
| Pathologie, précisions | HER2-positive Metastatic or Locally Advanced Breast Cancer |
| Déterminants de santé |
Iatrogenic Medicine |
| Mots-clés | Herceptin |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Roche Medical Data Center |
| Adresse | 4 cours de l'Ile Seguin - 92650 BOULOGNE-BILLANCOURT |
| data_sharing_france@roche.com | |
| Organisme | Roche SAS |
| Collaborations | |
| Participation à des projets, des réseaux, des consortiums |
No |
| Financements | |
| Financements |
Private |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Roche SAS |
| Statut de l’organisation |
Secteur Privé |
| Existence de comités scientifique ou de pilotage |
Yes |
| Contact(s) supplémentaire(s) | |
| Nom du contact | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Cohort study |
| Origine du recrutement des participants |
A selection of health institutions and services |
| Critère de sélection des participants |
Medication(s) taken |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Objectif de la base de données | |
| Objectif principal |
Primary objective: This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years.
Secondary objectives: The secondary objectives of this study were to describe: - The progression-free survival, time to progression and patients overall survival; - Modalities of use of trastuzumab, the duration of treatment and the reasons leading to treatment discontinuation; - Antineoplastic treatments in combination with trastuzumab and after discontinuation of trastuzumab treatment; - Relevant biological tumor markers; - The safety of trastuzumab treatment. |
| Critères d'inclusion |
Inclusion criteria:
- Woman >= 18 years; - With HER2-positive metastatic breast cancer or locally-advanced breast cancer; - Treated with trastuzumab as first-line therapy; - Without progression for at least 3 years after initiation of trastuzumab treatment; - Alive or not alive, and treated or not treated with trastuzumab at the time of inclusion; For patients alive at the time of inclusion: - Having been informed orally and in writing about the study and having given their written consent to the automatic processing of her personal data and their consultation by a duly authorized third party; - For the patients who accepted the centralized histological analysis of their primitive tumor, a written consent. Exclusion criteria: - Disease progression <3 years after beginning 1st-line therapy with Herceptin. |
| Type de population | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population concernée |
Sick population |
| Pathologie | D05 - Carcinoma in situ of breast |
| Sexe |
Woman |
| Champ géographique |
National |
| Collecte | |
| Dates | |
| Année du premier recueil | 2011 |
| Année du dernier recueil | 2012 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Détail du nombre d'individus | 160 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data |
| Données cliniques, précisions |
Medical registration |
| Détail des données cliniques recueillies | evaluation/inclusion criteria - initial breast cancer diagnosis - neo-adjuvant treatments - adjuvant treatments - entry in metastatic or locally advanced disease - adverse events since Herceptin® initiation - Progression - Evaluation at M6 and M12 - chemotherapy in 1st, 2nd and 3rd lines - hormonotherapy in 1st, 2nd and 3rd lines - Progression after 1 and 2nd lines - treatment by Herceptin® in neo-adjuvant/adjuvant - treatment by Herceptin® in metastatic |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Health event/mortality Health care consumption and services |
| Consommation de soins, précisions |
Medicines consumption |
| Modalités | |
| Mode de recueil des données | eCRF |
| Nomenclatures employées | CDISC |
| Procédures qualité utilisées | GCP/GVP |
| Suivi des participants |
Yes |
| Modalités de suivi des participants |
Monitoring by contact with the referring doctor |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Accès | |
| Site internet dédié | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Existence d’un document qui répertorie les variables et les modalités de codage |
Yes |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
