Completed
PHASE2
INTERVENTIONAL
NCT00320411
GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.
Interventions
Name:
lapatinib
Type:
DRUG
Description:
Lapatinib 1500mg QD
Primary Outcomes
Measure:
Overall Tumor Response
TimeFrame:
Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted.
Description:
Tumor response was measured as the number of participants achieving either a complete response (CR; disappearance of all target lesions) or partial response (PR; 30% decrease in the sum of the longest diameter of target lesions) among all participants who received study treatment. Tumor response was evaluated as the best response in accordance with response evaluation criteria in solid tumors (RECIST). Progressive disease: a 20% increase in the sum of the longest diameter of target lesions. Stable disease: small changes that do not meet the above-mentioned criteria.
Trial Information
NCT ID
NCT00320411
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
GlaxoSmithKline
Last Updated
December 15, 2025