Role of Early Versus Late Switch to Lapatinib-Capecitabine

Terminated

• Conditions: Cancer
• Interventions: Drug: Treatment

• Registration Number: NCT01357863
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all Brazilian States, 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).

Detailed Description

All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting can participate in this observational study, for a period of 12 months of observation since the start of the lapatinib-capecitabine treatment.

Study Timeline

• Study Start: 2010-07-15
• Primary Completion: 2010-12-13
• Study Completion: 2010-12-13
• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients on second line treatment	Treatment	Patients treated with Lapatinib-capecitabine immediately after first Trastuzumab-containing regimen progression
Patients on third or more lines treatment	Treatment	Patients treated with Lapatinib-capecitabine after 2 or more lines of treatment after first Trastuzumab-containing regimen progression

Primary Outcome Measures

Name	Time	Method
Time to disease progression (TTP)	One year	Time from the date of start of Lapatinib-capecitabine treatment until date of documented disease progression by the treating physician, determined by clinical and/or radiological assessment

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR) determined by treating physician	One year	Percentage of patients showing complete response (CR) and partial response (PR) to the given treatment
Clinical Global Impression (CGI)	One year	CGI assessment by the treating physician in the last visit (visit 4 or discontinuation visit)
One year overall survival (OS)	One year	Time from the start of lapatinib-capecitabine treatment until death due to any cause (measured at the end of follow-up)
Serious adverse events (SAEs)	One year	Describe lapatinib-related spontaneous reported serious adverse events

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇷 São Paulo, Brazil