Role of Early Versus Late Switch to Lapatinib-Capecitabine

GlaxoSmithKline3 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cancer

Interventions

TreatmentDRUG

Patients treated with Lapatinib-capecitabine after Trastuzumab progression

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

* 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.

Locations (13)

GSK Investigational Site

Vitória, Espírto Santo, Brazil

GSK Investigational Site

Salvador, Estado de Bahia, Brazil

GSK Investigational Site

Salvador, Estado de Bahia, Brazil

Outcomes

Primary Outcomes

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

Time frame: One year

Secondary Outcomes

Overall response rate (ORR) determined by treating physician

Percentage of patients showing complete response (CR) and partial response (PR) to the given treatment

Time frame: 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)

Time frame: One year

Serious adverse events (SAEs)

Describe lapatinib-related spontaneous reported serious adverse events

Time frame: One year

Clinical Global Impression (CGI)

CGI assessment by the treating physician in the last visit (visit 4 or discontinuation visit)

Time frame: One year

Data from ClinicalTrials.gov

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