Cancer
Conditions
Keywords
Lapatinib, Observational Study, Trastuzumab, Brazil, Metastatic Breast Cancer
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.
Interventions
DRUGTreatment
Patients treated with Lapatinib-capecitabine after Trastuzumab progression
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events (SAEs) | One year | Describe lapatinib-related spontaneous reported serious adverse events |
| 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) |
| 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) |
Countries
Brazil
Outcome results
None listed