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

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Roche Medical Data Center

Last update : 06/30/2022 | Version : 1 | ID : 74136

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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 LORHA
Scientific investigator(s) (Contact)
Name of the director Roche Medical Data Center
Address 4 cours de l'Ile Seguin - 92650 BOULOGNE-BILLANCOURT
Email 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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