FRESH-PEF74138-en
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.
KADOR
| Name | Country code |
|---|---|
| France | fr |
['Clinical data']
Individuals
| Topic | Vocabulary |
|---|---|
| Oncology | health theme |
| Carcinoma in situ of breast | cim-11 |
| Healthcare system determinants: Use of care | health determinant |
| Healthcare system determinants | health determinant |
{
"level_sex_clusion_I": [
{
"value": "Female",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
}
}
],
"level_age_clusion_I": [
{
"value": "Young Adult (19 to 24 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
}
},
{
"value": "Adult (25 to 44 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
}
},
{
"value": "Middle Aged (45 to 64 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008875"
}
},
{
"value": "Aged (65 to 79 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000368"
}
},
{
"value": "Aged, 80 and over (80 years and more)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000369"
}
}
],
"level_type_clusion_I": [
"Patients population"
],
"level_type_clusion_other": "",
"clusion_I": "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. ",
"clusion_E": "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."
}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2014-01-01 | 2018-01-01 |
| Standard |
|---|
| ['CDISC'] |
['GCP/GVP']
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
| Name | |
|---|---|
| ;Medical data center | data_sharing.france@roche.com |
FRESH-PEF74138-en
| Name | Affiliation |
|---|---|
| Camille BACHOT | F. HOFFMANN-LA ROCHE AG |