Metastatic Breast Cancer Clinical Trial
Official title:
Randomised, Open-label Phase II Study to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab or Lapatinib Plus Capecitabine in Trastuzumab-resistant HER2-overexpressing Metastatic Breast Cancer
The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab compared to lapatinib plus capecitabine as measured by investigator-assessed progression-free survival, tumour response and overall survival.
This is an open-label, randomized, explorative phase II trial of lapatinib plus trastuzumab
or lapatinib plus capecitabine in patients with HER2 overexpressing metastatic breast
cancer. The trial is designed to obtain some evidence wether chemotherapy-free combined
HER2-directed therapy with lapatinib and trastuzumab provides a similar efficacy as the
established combination of lapatinib with capecitabine and a more favourable toxicity
profile. This study will also assess the relationship between the anticipated anti-tumour
activity of the treatment regimens and biological characteristics of subjects' tumour at
baseline.
The purpose of this study is to estimate the clinical benefit of lapatinib plus trastuzumab
compared to lapatinib plus capecitabine as measured by investigator-assessed
progression-free survival, tumour response and overall survival.
The purpose of this study ist further
- to characterize the safety and tolerability of lapatinib plus trastuzumab in this
population.
- to identify predictors of sensitivity to lapatinib and trastuzumab therapy. and
- to compare the differences in health-related quality of life (HRQL) and pain symptoms
for patients by treatment assignment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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