Role of Early Versus Late Switch to Lapatinib-Capecitabine

• Status: Terminated
• Trial end date: 2010-12-13
• Target enrollment: 0
• Participant gender: Female

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Capecitabine; Lapatinib; Trastuzumab

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.