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This study was terminated because the National Ethics Committee has not approved the protocol.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on second line treatment | Patients treated with Lapatinib-capecitabine immediately after first Trastuzumab-containing regimen progression |
| |
| Patients on third or more lines treatment | Patients treated with Lapatinib-capecitabine after 2 or more lines of treatment after first Trastuzumab-containing regimen progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Drug | Patients treated with Lapatinib-capecitabine after Trastuzumab progression |
|
| 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 |
| 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) |
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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.
Centers from private and public settings, which have incorporated Lapatinib treatment in their routine clinical practice, will be included in this study. Data on the country, type of center, and facility name will be collected on the case report form for use in the data analysis.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Vitória | Espírto Santo | 29055-270 | Brazil | ||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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 |
| Salvador |
| Estado de Bahia |
| 40110150 |
| Brazil |
| GSK Investigational Site | Salvador | Estado de Bahia | 41810-570 | Brazil |
| GSK Investigational Site | Salvador | Estado de Bahia | 41825-010 | Brazil |
| GSK Investigational Site | Goiânia | Goiás | 74140-050 | Brazil |
| GSK Investigational Site | Goiânia | Goiás | 74605-070 | Brazil |
| GSK Investigational Site | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90430-090 | Brazil |
| GSK Investigational Site | Florianópolis | Santa Catarina | 88034-000 | Brazil |
| GSK Investigational Site | São José dos Campos | São Paulo | Brazil |
| GSK Investigational Site | Belo Horizonte | Brazil |
| GSK Investigational Site | Rio de Janeiro | 22793-080 | Brazil |
| GSK Investigational Site | São Paulo | 01239-040 | Brazil |