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  /    /  LACOG 0801 – GLICO

A randomized open-label, phase II study of lapatinib/capecitabine or lapatinib/vinorelbine or lapatinib/gemcitabine in subjects with Her2/neu amplified metastatic breast cancer patients progressing after taxanes treatment.

Type of Study: Clinical Trial

Sponsor / Support: LACOG, GAICO, GECOPERU, GSK, Novartis

Primary Objectives: To evaluate Clinical benefit rate (CBR) and safety profile of 2 experimental Lapatinib-chemotherapy combination regimens , Lapatinib- vinorelbine and Lapatinib -gemcitabine as well as the standard lapatinib capecitabine combination after taxanes progression in ErbB2+ metastatic breast Cancer patients. 

Design: This is a phase II, open-label, multicentric, international, randomized trial of lapatinb/capecitabine (control arm), lapatinib/vinorelbina (experimental) and lapatinib/gemcitabine (experimental) in ErbB2+ advanced or metastatic breast cancer patients that had progressed to taxanes.

Sample Size: 142 patients

Principal Investigator: Henry Gomez, Carlos Barrios

Countries LATAM: Brazil, Argentina and Peru Identifier: NCT01050322