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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
Study website Interactive tools
Created on
Feb 18, 2026
Last modified
Feb 18, 2026
Page views
67
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts

    • 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 Country code
    France fr
    Kind of Data

    ['Clinical data','Biological data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    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
    Keywords
    Herceptin® SC

    Coverage

    Universe

    {"level_sex_clusion_I":[{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"Inclusion criteria: - Woman suffering from HER2+ early-stage Breast cancer (Stage I, stage IIA, stage IIB, or stage IIIA breast cancer); - Woman eligible for neoadjuvant or adjuvant HER2+ treatment, according to national guidelines; - Woman aged 18 years or older; - Woman having received oral and written information about the study, without any objections for the use of her personal data and having signed a written informed consent form. ","clusion_E":"Woman previously treated with Herceptin® subcutaneous;- Woman participating in a clinical trial assessing an anticancer treatment."}

    Producers and sponsors

    Producers
    Name Role
    F. HOFFMANN-LA ROCHE AG sponsor

    Study authorization

    Agency
    Agency name
    Other

    Sampling

    Sample frame

    Unit Type

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

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access on specific project only
    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2015-01-01 2016-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"Transcription","vocab":"CESSDA"},"value":"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

    {"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}

    Contacts

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