Capecitabine (XELODA) With Or Without Lapatinib (GW572016) For Women With Refractory Advanced or Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

408

Participants

Timeline

Start Date

March 31, 2004

Primary Completion Date

April 30, 2006

Study Completion Date

February 28, 2010

Conditions
Breast Cancer
Interventions
DRUG

capecitabine

Capecitabine daily dose divided and given twice daily orally, for 14 days, every 21 days. The capecitabine starting dose for the monotherapy arm was 2500 mg/m2 and for the combination arm was 2000 mg/m2.

DRUG

lapatinib (GW572016)

Lapatinib 1250 mg orally once daily

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY