National Data Archive
Data Catalog
  • Home
  • Microdata Catalog
  • Citations
  • Login
    Login
    Home / Central Data Catalog / FRESH-PEF74136-EN
central

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 Stil

France, 2011 - 2012
Reference ID
FRESH-PEF74136-en
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
4
  • 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-PEF74136-en

    Title

    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

    Abbreviation or Acronym

    LORHA

    Country
    Name
    France
    Abstract

    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.

    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
    2011 2012
    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 event/morbidity Health event/mortality 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-PEF74136-en

    Back to Catalog
    National Data Archive

    © National Data Archive, All Rights Reserved.