Trial Information

Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)

Lapatinib in combination with capecitabine is a standard of care treatment for ErbB2+
metastatic breast cancer (MBC) patients who have progressed after anthracyclines, taxanes
and trastuzumab treatment. Results from the lapatinib pivotal trial showed that the addition
of lapatinib to capecitabine increased median time to progression (TTP) even among heavily
pre-treated patients (median of 4 prior lines of therapy). A recent ad hoc subset analysis
of this trial suggested that earlier administration of lapatinib-capecitabine in MBC
patients who progress after trastuzumab may produce better clinical outcomes. The TYCO study
was designed to evaluate if early switch to lapatinib-capecitabine in patients with ErbB2+
MBC who have progressed on trastuzumab-containing regimen improves TTP in comparison with a
later start (after several lines of therapy). Secondary objectives include Overall Response
Rate (ORR), 1 year Overall Survival (OS), and description of reported serious adverse
events. This is an international, multicenter, prospective, observational
(non-interventional) study in 269 ErbB2+MBC patients whose disease has progressed after
treatment with trastuzumab. Two cohorts will be compared; Group 1: patients receiving
lapatinib-capecitabine immediately after first trastuzumab progression, and Group 2:
patients receiving lapatinib-capecitabine after two or more lines of treatment after first
trastuzumab progression. Eligibility criteria include females aged 18 or more with confirmed
ErbB2+ MBC who have progressed after a previous trastuzumab-containing regimen, eligible to
start standard therapy with lapatinib-capecitabine at approved conventional doses, as per
local label approval. The study duration is of 12 months with data collection at baseline
and approximately every 3 months thereafter. Patient evaluations will be conducted per
standard patient care in each center and TTP will be determined by the treating physician
(clinically or radiologically). Enrollment started in February 2010 and completion of
accrual is estimated for December 2011.