ITMO public health
Last update : 06/30/2022 | Version : 1 | ID : 74136
| General | |
| Identification | |
| Detailed name | 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 |
| Sign or acronym | LORHA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML23001 |
| General Aspects | |
| Medical area |
Cancer research |
| Study in connection with Covid-19 |
No |
| Pathology (details) | HER2-positive Metastatic or Locally Advanced Breast Cancer |
| Health determinants |
Iatrogenic Medicine |
| Keywords | Herceptin |
| 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: 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. |
| Inclusion criteria |
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. |
| 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) | 2011 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 160 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | 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 |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality 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 |
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