Preoperative Chemotherapy With Paclitaxel, Gemcitabine, and Lapatinib (Tykerb®) (PGT)

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

June 30, 2010

Study Completion Date

October 31, 2011

Conditions
Breast Cancer
Interventions
DRUG

paclitaxel, gemcitabine, lapatinib

Patients receive paclitaxel and gemcitabine intravenously (iv) on day 1 and 8, and oral lapatinib once daily. Lapatinib with fixed dose will be given once a day p.o. from day 1 without resting during each cycle. The starting doses of paclitaxel 80mg/m2 and gemcitabine 1000mg/m2 iv, on day 1 and 8, and lapatinib 1000mg p.o., daily (dose level 1) will be administered every 21 days.

Trial Locations (1)

410-769

National Cancer Center, Goyang-si

Sponsors
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

HK inno.N Corporation

INDUSTRY

lead

Jungsil Ro

OTHER_GOV