Last updated: 03/04/2020 21:00:18

PH+oeBE-Patterns of care in HER2+ metastatic Breast cancer in Europe: A representative, retrospective study in FrancePH+oeBE

GSK study ID
200641
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: PH+oeBE-Patterns of care in HER2+ metastatic Breast cancer in Europe: A representative, retrospective study in France
Trial description: The objective of the PH+oeBE study is to describe the current and real-life treatment patterns for the management of HER2-positive metastatic breast cancer especially among patients receiving lapatinib containing regimens
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Describe the demographic and clinical characteristics of HER2+ metastatic breast cancer patients

Timeframe: January 2011 to July 2014

Utilisation of lapatinib plus aromatase inhibitor among HER2+ metastatic breast cancer patients

Timeframe: January 2011 to July 2014

Utilisation of anti-HER2 therapy among HER2+ metastatic breast cancer patients

Timeframe: January 2011 to July 2014

Utilisation of lapatinib plus capecitabine among HER2+ metastatic breast cancer patients

Timeframe: January 2011 to July 2014

Utilisation of lapatinib in combination with trastuzumab (dual blockade) among HER2+ metastatic breast cancer patients

Timeframe: January 2011 to July 2014

Secondary outcomes:

-

Timeframe: -

Interventions:
  • Drug: A description of the various types of treatments
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Breast
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    April 2015 to August 2015
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • 1.Female adults aged 18 years or older at diagnosis of, or progression to, metastatic breast cancer.
    • 2.A diagnosis of breast cancer with documented metastatic disease and with known date of metastatic disease.
    • 1.Receiving care for another primary cancer during the study time period.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 1.Female adults aged 18 years or older at diagnosis of, or progression to, metastatic breast cancer. 2.A diagnosis of breast cancer with documented metastatic disease and with known date of metastatic disease. 3.Histologically confirmed HER2+ breast cancer (HER2 testing procedures per routine institutional practice; no tissue re-sampling will be performed. If conducted at another site, documented results must be available).
    Exclusion criteria:
    • 1.Receiving care for another primary cancer during the study time period.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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