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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01985893
Study type Interventional
Source Berufsverband Niedergelassener Gynäkologischer Onkologen in Deutschland e.V.
Contact
Status Withdrawn
Phase Phase 2
Start date September 2013
Completion date March 2015

See also
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