A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer

PHASE2WithdrawnINTERVENTIONAL

Timeline

Start Date

October 31, 2011

Primary Completion Date

December 31, 2016

Study Completion Date

March 31, 2018

Conditions

Neoplasms, Breast

Interventions

DRUG

Lapatinib

oral, reversible small molecule tyrosine kinase inhibitor of HER2 receptor

BIOLOGICAL

Trastuzumab

monoclonal antibody directed to HER2 receptor

DRUG

Docetaxel

Taxane chemotherapy

DRUG

Paclitaxel

Taxane chemotherapy

DRUG

Vinorelbine

Vinka alkaloid