Last updated: 03/04/2020 20:50:08

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

GSK study ID
200312
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: patients: A representative, retrospective study in Croatia
Trial description: This study will describe the treatment paradigm used over recent years in the clinical management of human epidermal growth factor receptor 2 (HER2)+ metastatic breast cancer (MBC) in Croatia. This information will provide insight into real-world exposure and adherence to anti-HER2 therapy containing regimens, and improve understanding of the reasons for discontinuation of this therapy. This is a retrospective, descriptive, cohort study of approximately 100 female patients diagnosed with HER2-postive metastatic breast cancer in Croatia. Patients diagnosed with, or who progressed to, metastatic disease between 01 Jul 2009 and 01 Jan 2012 will be included. All patients will be followed until death, loss to follow-up or the end of the study period (01 Jan 2014). All data will be collected retrospectively from patient medical records. Descriptive statistics of the demographic and clinical characteristics of HER2+ metastatic breast cancer patients, including sites of metastases, the time from initial breast cancer diagnosis until diagnosis of metastatic disease, and HER2 testing methodology and status of HER2 will be described. Further, descriptive statistics of the proportion of HER2+ metastatic breast cancer patients who received anti-HER2 therapy, the sequencing of different therapies, and the duration of therapies in the metastatic setting will be analysed. Among the subset of women who receive lapatinib plus capecitabine, descriptive statistics of the timing of initiation of lapatinib plus capecitabine in the metastatic treatment pathway, time to treatment discontinuation and time to progression (TTP) on lapatinib plus capecitabine will be calculated. Further, descriptive statistics of the type and duration anti-HER2 therapies used prior to initiation of lapatinib plus capecitabine and, where relevant, after lapatinib+capecitabine will be performed.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Time to progression (TTP) of lapatinib based therapy expressed in weeks and months

Timeframe: 24 Months

Secondary outcomes:

Time to discontinuation of lapatinib based therapy, expressed in weeks and months.

Timeframe: 24 months

Interventions:
  • Drug: Lapatinib plus capecitabine
  • 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)
    February 2015 to March 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Patients who meet the following criteria will be included in the study:
    • Female adults aged 18 years or older at diagnosis of, or progression to, metastatic breast cancer.
    • Patients who meet the following criteria will be excluded from the study:
    • 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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