A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab plus Pertuzumab plus a taxane following anthtracyclines vs Trastuzumab Emtansine plus Pertuzumab following Anthracycline as Adjuvant Therapy in Patients with Operable HER2-positive Primary Breast Cancer

Print this page

A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab plus Pertuzumab plus a taxane following anthtracyclines vs Trastuzumab Emtansine plus Pertuzumab following Anthracycline as Adjuvant Therapy in Patients with Operable HER2-positive Primary Breast Cancer

Efficacy Objectives
The co-primary efficacy objectives for this study are as follows:
To compare invasive disease-free survival in the node positive subpopulation and in the overall protocol-defined population of patients with human epidermal growth (HER) factor-2-positive breast cancer randomized to either receive a taxane and 1 year of trastuzumab plus pertuzumab following anthracycline-based chemotherapy or 1 year of
trastuzumab emtansine plus pertuzumab following anthracycline-based chemotherapy
The secondary efficacy objectives for this study are as follows:To compare IDFS plus second non-breast primary cancers, disease-free survival,
and distance recurrence-free interval in the node-positive subpopulation and
in the overall protocol-defined population between the two treatment arms
To compare overall survival in the node-positve subpopulation and in the
overall protocol-defined population between the two treatment arms
Safety Objectives
The safety objectives for this study are as follows:
To compare overall safety, cardiac safety, hepatic, and pulmonary safety in the overallprotocol-defined population between the two treatment arms

Protocol Number041318
Principal InvestigatorDeborah Toppmeyer
PhasePhase III
ScopeNational
Applicable Disease SitesBreast - Female
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedDOXORUBICIN
CYCLOPHOSPHAMIDE
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.