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An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer

France, 2015 - 2016
Reference ID
FRESH-PEF74135-en
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
4
  • 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-PEF74135-en
    Title

    An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
    Abbreviation or Acronym

    HERMIONE
    Country
    Name
    France
    Abstract

    Primary objective: To describe the systemic safety and local tolerability of subcutaneous Herceptin® (SC) in patients with HER2-positive early breast cancer (eBC), naive and non-naive of HER2+ treatment, treated in the neoadjuvant and adjuvant setting in routine clinical practice use. Secondary objective: To describe the quality of life (QoL) of patients (using the European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 questionnaire) - The description of the baseline and disease characteristics of patients with HER2+ eBC initiating a treatment with Herceptin® SC; - The description of use of Herceptin® SC (treatment duration, frequency of injections and sites of injection).
    Kind of Data

    ['Clinical data','Biological 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® SC

    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
    2015 2016
    Time Method

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

    Study activities

    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception

    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-PEF74135-en
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