drugset / Trial / NCT01160211

A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer

NCT01160211

Phase 3 Completed 369 enrolled Novartis Pharmaceuticals GlaxoSmithKline · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

Timeline

Start
2011-05-05
Primary completion
2016-03-11
Completion
2022-06-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lapatinib Small molecule 1000 mg Oral
Comparator Lapatinib Small molecule 1500 mg Oral
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Anastrozole Other / unclassified Oral
Background Exemestane Small molecule Oral
Background Letrozole Other / unclassified Oral

Indications