Last updated: 11/03/2018 19:38:32

Indirect comparison lapatinib+capecitabine vs trastuzumab+capecitabine in metastic breast cancer

GSK study ID
116805
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: Indirect comparison lapatinib+capecitabine vs trastuzumab+capecitabine in metastic breast cancer
Trial description: An indirect comparison of lapatinib plus capecitabine versus trastuzumab plus capecitabine was conducted by using data from two studies:
• EGF100151 (a phase III randomised, open-label, global, multi-centre, parallel-group trial to evaluate and compare the treatment of lapatinib plus capecitabine versus capecitabine alone in women with HER2 positive advanced or metastatic breast cancer who had received prior therapy which included anthracyclines and taxanes in any setting and trastuzumab in the metastatic setting) (Geyer 2006, Cameron 2008 and Cameron 2010).
• GBG 26 (phase III open label randomised trial that evaluated trastuzumab in combination with capecitabine compared to capecitabine monotherapy in HER2 positive metastatic breast cancer patients who had progressed on trastuzumab whilst in the first line metastatic setting) (von Minckwitz 2009 and von Minckwitz 2011).
EGF100151 and GBG 26 were identified from a systematic review of randomised controlled trials (RCTs) of regimens, lapatinib plus capecitabine and trastuzumab plus capecitabine and vinorelbine plus capecitabine, in breast cancer patients with advanced or metastatic disease whose tumours over-express HER2 positive with progression following prior therapy which must have included anthracyclines and taxanes in any setting and therapy with trastuzumab in the metastatic setting. For inclusion in the review, at least 50% of the patients recruited in the trial must have had prior treatment with anthracyclines and taxanes in any setting and at least 90% of the patients must have had trastuzumab containing regimens in the metastatic setting.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Median time to progression

Timeframe: over duration of studies

Secondary outcomes:

Overall survival

Timeframe: over duration of studies

Interventions:
  • Drug: Capecitabin
  • Drug: Trastuzumab
  • Drug: Lapatinib
  • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Breast
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    February 2012 to February 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Included in either EGF100151 or GBG26

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Protocol
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-29-02

    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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