Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

121

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Neoplasms, Breast
Interventions
DRUG

lapatinib

Arm B 1250mg/d PO Arm C 750mg/d PO

BIOLOGICAL

trastuzumab

First dose 4mg/kg in 60mins, then weekly 2mg/kg in 30 mins

DRUG

paclitaxel

80mg/sqm 1 hour infusion for 12 weeks

DRUG

fluorouracil

600mg/sqm iv day 1 q21 days for four coursess

DRUG

epidoxorubicin

75mg/sqm iv day 1 q21 days for four courses

DRUG

cyclophosphamide

600mg/sqm day 1 q21 days for four courses

Trial Locations (17)

10060

GSK Investigational Site, Candiolo (TO)

13125

GSK Investigational Site, Berlin

21100

GSK Investigational Site, Varese

24047

GSK Investigational Site, Treviglio (BG)

26100

GSK Investigational Site, Cremona

27100

GSK Investigational Site, Pavia

29100

GSK Investigational Site, Piacenza

41012

GSK Investigational Site, Carpi (MO)

41100

GSK Investigational Site, Modena

42100

GSK Investigational Site, Reggio Emilia

43100

GSK Investigational Site, Parma

47100

GSK Investigational Site, Forlì

47900

GSK Investigational Site, Rimini

56126

GSK Investigational Site, Pisa

72100

GSK Investigational Site, Brindisi

06156

GSK Investigational Site, Perugia

00-909

GSK Investigational Site, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY