FRESH-PEF74136-en
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
LORHA
| Name |
|---|
| France |
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.
['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 |
|---|---|
| 2011 | 2012 |
Longitudinal or cohort study
| Standard |
|---|
| ['CDISC'] |
GCP/GVP
Restricted access
| Name | |
|---|---|
| Medical data center | data_sharing.france@roche.com |
FRESH-PEF74136-en