Role of Early Versus Late Switch to Lapatinib-Capecitabine ((TYCO1))

GlaxoSmithKline (GSK)

Status

Terminated

Conditions

Cancer

Treatments

Drug: Treatment

Study type

Observational

Funder types

Industry

Identifiers

NCT01357863

113960

Details and patient eligibility

About

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).

Full 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.

Enrollment

3 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.