Novel Capecitabine Dosing Schedule in Combination With Lapatinib, Based on the Norton-Simon Mathematical Method in Patients With HER2 Overexpressed/Amplified, Trastuzumab (Herceptin) -Refractory, Metastatic Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Breast Cancer
Interventions
DRUG

capecitabine, lapatinib

Capecitabine 2,000mg twice daily for 7 days followed by a 7-day rest in combination with lapatinib 1,250mg orally daily. Cycle length is 28 days (+/- 2 days).Toxicity assessment will occur q2 weeks for the first 4 weeks, then q4 weeks(+/- 2 days). Radiographic response assessment will take place q12 weeks (+/- 1 week). LVEF assessment will be repeated q12 weeks (+/- 1 week).

Trial Locations (5)

10065

Memorial Sloan-Kettering Cancer Center, New York

10591

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow

11570

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center, Rockville Centre

11725

Memorial Sloan-Kettering Cancer Center at Commack, Commack

07920

Memorial Sloan-Kettering at Basking Ridge, Basking Ridge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER