Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2010

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Neoplasms, Breast
Interventions
DRUG

Lapatinib

Lapatinib 1000 mg orally once daily continuously

DRUG

Trastuzumab

Part II (Week 13-24) Trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV Day 1 of each week

DRUG

Epirubicin

Part I (Week 1-12) Epirubicin 90 mg/m2 by IV infusion on Day 1 every 21 days

DRUG

Cyclophosphamide

Part I (Week 1-12) Cyclophosphamide 600 mg/m2 by IV infusion on Day 1 every 21 days

DRUG

Paclitaxel

Part II (Week 13-24) Paclitaxel 80 mg/m2 by IV infusion on Day 1 of each week

Trial Locations (6)

1122

GSK Investigational Site, Budapest

5700

GSK Investigational Site, Gyula

12002

GSK Investigational Site, Castellon

A-8036

GSK Investigational Site, Graz

0310

GSK Investigational Site, Oslo

0407

GSK Investigational Site, Oslo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01205217 - Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer | Biotech Hunter | Biotech Hunter