Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients

Phase 2 Completed 102 enrolled Spanish Breast Cancer Research Group GlaxoSmithKline · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Phase II randomized multicenter trial to compare Epirubicin and Cyclophosphamide plus Docetaxel and Trastuzumab with Epirubicin and Cyclophosphamide plus Docetaxel and Lapatinib for patients with positive HER2 and resectable or locally advanced breast cancer.

Timeline

Start: 2009-02
Primary completion: 2011-12
Completion: 2013-12

Outcome

Met primary endpoint

paper Pathological complete response in breast was 52.1% (95% CI:38.0-66.2%) for EC-DT and 25.5% (95% CI:13.5-37.5%) for EC-DL (P=0.0065). PMID 24457911 ↗

Publications

Results Alba E, Albanell J, de la Haba J, Barnadas A, Calvo L, Sanchez-Rovira P, Ramos M, Rojo F, Burgues O, Carrasco E, Caballero R, Porras I, Tibau A, Camara MC, Lluch A. Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial. Br J Cancer. 2014 Mar 4;110(5):1139-47. doi: 10.1038/bjc.2013.831. Epub 2014 Jan 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	100 mg/m2	Intravenous
Subject	Lapatinib	Small molecule	1250 mg	Oral
Comparator	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Background	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Background	Epirubicin	Small molecule	90 mg/m2	Intravenous