KADOR - A French retrospective study describing the epidemiology and the therapeutic management of patients treated by Herceptin® based neoadjuvant treatment for HER2-positive early breast cancer.
Head :
Roche Medical Data Center
Last update : 06/30/2022 | Version : 1 | ID : 74138
| General | |
| Identification | |
| Detailed name | A French retrospective study describing the epidemiology and the therapeutic management of patients treated by Herceptin® based neoadjuvant treatment for HER2-positive early breast cancer. |
| Sign or acronym | KADOR |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML41346 |
| General Aspects | |
| Medical area |
Cancer research |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Early HER2+ Breast cancer |
| Health determinants |
Medicine |
| Keywords | KADOR |
| 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 therapeutic management of HER2-positive early breast cancer adults’ patients who have received an adjuvant treatment following Herceptin® based neoadjuvant therapy and breast surgery.
Secondary objectives: The 2 key secondary objectives are: 1. To describe the clinical characteristics of the patients included in the cohort, overall and per pathological response status; 2. To measure the invasive disease-free survival (IDFS) and overall survival (OS), according to pathologic response status. Other objectives: 3. To characterize adjuvant treatment failure outcomes including death, disease progression, and relapses; 4. To describe health care resources utilization by the targeted patients; 5. To estimate the number of HER2-positive early breast cancer patients who underwent breast surgery following Herceptin® based neoadjuvant treatment in France over a year (through the constitution of a registry of these patients) and number of HER2 positive early breast cancer patients with non pCR. |
| Inclusion criteria |
Inclusion criteria:
- A confirmed diagnosis of HER2-positive early breast cancer; - Initiated Herceptin® based neoadjuvant treatment during 2014 (inclusion period) followed by a breast surgery; - A visit to any of the oncologist participating in the study during the 1-year inclusion period. Exclusion criteria: -Patients with bilateral breast cancer, or participating in a clinical trial for neoadjuvant or adjuvant treatment, or already included in the registry of another participating site of the study, or who expressed disagreement on the use of their medical data will be excluded from the site’s registry. |
| 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) | 2014 |
| Date of last collection (YYYY or MM/YYYY) | 2018 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 301 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Neoadjuvant treatment strategy and non-drugs treatments (surgery and radiotherapy) - Adjuvant treatment strategy and modification - Inclusion criteria variables, demographic, anthropometric, clinical and cancer characteristics - Weight, comorbidities of interest at the time of adjuvant treatment initiation - Date of last visit of the patient during the follow-up period, disease progression and reason for earlier end of observation or follow-up - Health care resources utilizations - Start and end date of patient inclusion in the registry - Date of inclusion of the first patient included and the last patient included in the registry - Number of consultations at the site during the inclusion year - Adjuvant treatment with trastuzumab (yes/No) - Type of surgery and pathologic response status. |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| 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 |
| 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 |
