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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.

France, 2014 - 2018
Reference ID
FRESH-PEF74138-en
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
3
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF74138-en

    Title

    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.

    Abbreviation or Acronym

    KADOR

    Country
    Name
    France
    Abstract

    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.

    Kind of Data

    ['Clinical data']

    Unit of Analysis

    Individuals

    Scope

    Topics
    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
    Keywords
    Herceptin

    Coverage

    Universe

    {
    "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": ""
    }

    Producers and sponsors

    Producers
    Name Role
    F. HOFFMANN-LA ROCHE AG sponsor

    Study authorization

    Agency
    Agency name
    Autre

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']

    Sampling Procedure

    ['Other']

    Survey instrument

    Questionnaires

    Access on specific project only

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2014 2018
    Time Method

    Longitudinal or cohort study

    Mode of data collection
    • Converting or copying information into a structured record

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Health care consumption and services

    Quality standards

    Quality standards
    Standard
    ['CDISC']
    Other quality statement

    GCP/GVP

    Data Access

    Availability Status

    Restricted access

    Contacts

    Contacts
    Name Email
    Medical data center data_sharing.france@roche.com

    Metadata production

    DDI Document ID

    FRESH-PEF74138-en

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