LAPS - Female patients with breast cancer treated with lapatinib in the context of an expanded access program (ATU): description of the care trajectory and clinical course 
Head :
Leclerc-Zwirn Christel, Laboratoire GSK
Last update : 01/01/2020 | Version : 1 | ID : 155
| General | |
| Identification | |
| Detailed name | Female patients with breast cancer treated with lapatinib in the context of an expanded access program (ATU): description of the care trajectory and clinical course |
| Sign or acronym | LAPS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 1213267 |
| General Aspects | |
| Medical area |
Cancer research |
| Others (details) | Breast cancer |
| Keywords | HER2+, Tyverb |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Phone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | Laboratoire GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | GSK laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Laboratoire GSK |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| 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 |
| Additional information regarding sample selection. |
One hundred centers have filed at least one TUA request as of July 31, 2007 (about 3 months before the initiation of the study): about thirty of these are centers of substantial size (at least 5 patients, 10 patients on the average), the other 70 are small centers (less than 5 patients, 4 patients on the average). The study will be proposed to 80% of the centers in each stratum (center size). The random drawing will make it possible, as such, to retain 56 small centers and 25 large centers. Based on an estimated response rate of 70%, 40 small centers and 18 large centers will in the end participate in the study: Random drawing and number of patients expected: Based on the eligibility criteria retained, an additional CRF will have to be completed for all of the patients of a center. No random drawing will be carried out at this level. Approximately 570 patients received a treatment via lapatinib over the period of the study retained. Based on participation of 58 of the 81 centers that had requested a TUA, to which this study will be proposed, 330 completed dossiers can be expected. |
| Database objective | |
| Main objective | Describe the care pathways of patients with breast cancer who have received and/or are receiving treatment with lapatinib under Temporary Use Authorization (TUA) |
| Inclusion criteria | Patient who has received lapatinib for the treatment of breast cancer within the framework of a TUA between January 1, 2007 and 3 months prior to the beginning of the study |
| 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 |
| Gender |
Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 198 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | The investigating centers (prescribing doctor) that have accepted to carry out the study will receive a CRF for all of their patients eligible for the study: patient number, sex, age and treatment start date will be pre-completed in order to identify the patients. Prescribing doctors will complete the CRF using the medical doctor, based on the information available, and will return it to the logistics center |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Abstract (ISPOR 2009) Publication in progress |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
