Last updated: 11/03/2018 22:27:51

HO-14-15662 - Tykerb/Tyverb Efficacy and Sequence of Treatment in HER2+ metastatic Breast Cancer (TESTER)

GSK study ID
203045
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: HO-14-15662 - Tykerb/Tyverb Efficacy and Sequence of Treatment in HER2+ metastatic Breast Cancer (TESTER)
Trial description: The aim of this retrospective study is to examine patient characteristics, treatment patterns, and outcomes including progression free survival (PFS), overall survival (OS), and best overall response in a sample of patients diagnosed with human epidermal growth factor receptor 2-postive (HER2+) metastatic breast cancer (MBC) with a record of lapatinib or T-DM1.This study also aims to examine rates of development of brain metastases and the extent to which lapatinib is prematurely discontinued due to rash and diarrhea among patients with HER2+ MBC treated in community oncology practices.
TYKERB/TYVERB are registered trademarks of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Progression-free survival

Timeframe: Up to 6 years

Overall survival treatment response

Timeframe: Up to 6 years

Treatment patterns

Timeframe: Up to 6 years

Secondary outcomes:

Frequency and severity of diarrhea and rash

Timeframe: Up to 6 years

Association of diarrhea and rash with early discontinuation of lapatinib

Timeframe: Up to 6 years

Rate of occurrence of brain metastases

Timeframe: Up to 6 years

Interventions:
  • Drug: lapatinib
    • Enrollment:
    1
    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)
    January 2015 to May 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Diagnosis of malignant neoplasm of the female breast
    • Stage IV breast cancer
    • Patients with documentation of negative HER2 status
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis of malignant neoplasm of the female breast
    • Stage IV breast cancer
    • Age ≥18 years at time of Stage IV breast cancer diagnosis
    • Received a third or later line of therapy as per protocol section 3.3.2
    • Initiated third line therapy on or after January 1, 2008
    Exclusion criteria:
    • Patients with documentation of negative HER2 status

    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
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2015-30-05

    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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