Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

February 28, 2007

Study Completion Date

May 31, 2007

Conditions
Metastatic Breast Cancer
Interventions
DRUG

humanized anti-HER2 antibody

Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks.

DRUG

Vinorelbine

Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks

Trial Locations (1)

100021

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
lead

Shanghai CP Guojian Pharmaceutical Co., Ltd.

INDUSTRY

NCT01439191 - Study of Cipterbin®, Used Alone or With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter