Last updated: 11/03/2018 19:38:32
Indirect comparison lapatinib+capecitabine vs trastuzumab+capecitabine in metastic breast cancer
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
- Included in either EGF100151 or GBG26
Inclusion and exclusion criteria
Inclusion criteria:
- 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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