A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients with Her2+ Metastatic Breast Cancer Who Have Received Two or More Prior Her2-Directed Regimens in the Metastatic Setting

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A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients with Her2+ Metastatic Breast Cancer Who Have Received Two or More Prior Her2-Directed Regimens in the Metastatic Setting

The co-primary objectives of this study are:
1) to compare independently adjudicated PFS following treatment with neratinib plus capecitabine versus lapatinib plus capecitabine in patients with HER2+ MBC who have received two or more prior HER2-directed regimens in the metastatic setting.
2) to compare OS following treatment with neratinib plus capecitabine versus lapatinib plus capecitabine in this population.
3.2 Secondary Objectives
The secondary objectives of this study are to compare between the two treatment groups:Investigator-assessed PFS, Objective response rate (ORR), duration of response (DOR) and clinical benefit rate (CBR)
(complete response [CR] or partial response [PR] or stable disease [SD] ?24 weeks), time to intervention for symptomatic metastatic central nervous system (CNS) disease, safety (AEs, serious adverse events [SAEs]), health outcomes assessments.

Protocol Number041304
Principal InvestigatorSerena Wong
PhasePhase III
ScopeNational
Applicable Disease SitesBreast - Female
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedNeratinib
CAPECITABINE
LAPATINIB
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.