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 |
|---|
| France |
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.
['Clinical data']
Individuals
| Topic | Vocabulary | URI |
|---|---|---|
| Oncology | health theme | |
| cim-11 | http://id.who.int/icd/entity/846453488 | |
| Healthcare system determinants: Use of care | health determinant | |
| Healthcare system determinants | health determinant |
{
"level_sex_clusion_I": [
"Female"
],
"level_age_clusion_I": [
"Young Adult (19 to 24 years)",
"Adult (25 to 44 years)",
"Middle Aged (45 to 64 years)",
"Aged (65 to 79 years)",
"Aged, 80 and over (80 years and more)"
],
"level_type_clusion_I": [
"Patients population"
],
"level_type_clusion_other": "",
"clusion_I": "",
"clusion_E": ""
}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
| Agency name |
|---|
| Autre |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['Other']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2014 | 2018 |
Longitudinal or cohort study
| Standard |
|---|
| ['CDISC'] |
GCP/GVP
Restricted access
| Name | |
|---|---|
| Medical data center | data_sharing.france@roche.com |
FRESH-PEF74138-en