Role of Early Versus Late Switch to Lapatinib-Capecitabine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO1) - Brazil

Conditions
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Cancer

Intervention / Treatment
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* Drug: Treatment


Participation Criteria
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Eligibility Criteria
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Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice); Older than 18 years old; Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer; Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment; Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, in the community setting; Signed consent to participate and release information for this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients on second line treatment<br>Patients treated with Lapatinib-capecitabine immediately after first Trastuzumab-containing regimen progression | Drug: Treatment<br>* Patients treated with Lapatinib-capecitabine after Trastuzumab progression<br>|
| Patients on third or more lines treatment<br>Patients treated with Lapatinib-capecitabine after 2 or more lines of treatment after first Trastuzumab-containing regimen progression | Drug: Treatment<br>* Patients treated with Lapatinib-capecitabine after Trastuzumab progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression (TTP) | 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 | One year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lapatinib, Observational Study, Trastuzumab, Brazil, Metastatic Breast Cancer