ITMO public health
Last update : 06/30/2022 | Version : 1 | ID : 74135
| General | |
| Identification | |
| Detailed name | An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer |
| Sign or acronym | HERMIONE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML28983 |
| General Aspects | |
| Medical area |
Cancer research |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Early HER2+ Breast cancer |
| Health determinants |
Iatrogenic Medicine |
| Keywords | Herceptin® SC |
| Scientific investigator(s) (Contact) | |
| Name of the director | Roche Medical Data Center |
| Address | 4 cours de l'Ile Seguin - 92650 BOULOGNE-BILLANCOURT |
| data_sharing_france@roche.com | |
| Organization | Roche SAS |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Roche SAS |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
Primary objective: To describe the systemic safety and local tolerability of subcutaneous Herceptin® (SC) in patients with HER2-positive early breast cancer (eBC), naive and non-naive of HER2+ treatment, treated in the neoadjuvant and adjuvant setting in routine clinical practice use.
Secondary objective: To describe the quality of life (QoL) of patients (using the European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 questionnaire) - The description of the baseline and disease characteristics of patients with HER2+ eBC initiating a treatment with Herceptin® SC; - The description of use of Herceptin® SC (treatment duration, frequency of injections and sites of injection). |
| Inclusion criteria |
Inclusion criteria:
- Woman suffering from HER2+ early-stage Breast cancer (Stage I, stage IIA, stage IIB, or stage IIIA breast cancer); - Woman eligible for neoadjuvant or adjuvant HER2+ treatment, according to national guidelines; - Woman aged 18 years or older; - Woman having received oral and written information about the study, without any objections for the use of her personal data and having signed a written informed consent form. Exclusion criteria: -Woman previously treated with Herceptin® subcutaneous; - Woman participating in a clinical trial assessing an anticancer treatment. |
| Population type | |
| 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 covered |
Sick population |
| Pathology | D05 - Carcinoma in situ of breast |
| Gender |
Woman |
| Geography area |
National |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2015 |
| Date of last collection (YYYY or MM/YYYY) | 2016 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 511 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Validation of inclusion and exclusion criteria - Dates of visits (or data of last contact with the patient) - Demographic - CKD history and evolution - Comorbidities - Most recent clinical and biological data - Previous and/or ongoing CKD treatments - Other specific treatments - Previous and/or ongoing anemia treatments - Treatment with Micera® - Adverses events - Reason for early study discontinuation. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | eCRF |
| Classifications used | CDISC |
| Quality procedure(s) used | GCP/GVP |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Followed pathology | D05 - Carcinoma in situ of breast |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Presence of document that lists variables and coding procedures |
Yes |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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