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Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO) — TYCO  

Cancer Clinical Trial

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

Clinical Trial Summary

It will be conducted as an international multicenter prospective observational cohort study in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).

Clinical Trial Description

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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01160094
Study type Observational
Source Novartis
Contact
Status Completed
Phase N/A
Start date February 2010
Completion date July 2013
View Details
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