NCT00169104 - Effects of Granulocyte Colony-stimulating Factor (G-CSF), Trastuzumab, and Vinorelbine on Immune Cell Function | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

March 31, 2009

Study Completion Date

March 31, 2009

Conditions

Metastatic Breast Cancer

Interventions

DRUG

G-CSF

5 mcgm/kg daily Monday through Friday weeks 3-14

DRUG

trastuzumab

4 mcgm/kg intravenously (IV) over 90 minutes week 1, then 2 mg/kg IV over 30 minutes weeks 2-14

DRUG

vinorelbine

25 mg/m2 over 6 minutes IV weekly, weeks 3, 4, 6, 7, 9, 10, 12, 13

DRUG

G-CSF

5 mcgm/kg SQ daily for ten days, Monday through Friday of the first two weeks of the study

DRUG

saline placebo

Saline will be given SQ daily for ten days, Monday through Friday of the first two weeks of the study