A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

580

Participants

Timeline

Start Date

June 27, 2019

Primary Completion Date

April 26, 2023

Study Completion Date

April 26, 2023

Conditions
HER2-positive Early Breast Cancer
Interventions
DRUG

SIBP-01

IBP-01: injection; strength: 150mg; first dose 8mg/kg (intravenous infusion, not less than 90 minutes, on the 1st day of each cycle), then 6mg/kg once every 3 weeks, totaling 6 cycles

DRUG

Herceptin

Herceptin: injection; strength: 440mg; first dose 8mg/kg (intravenous infusion, not less than 90 minutes, on the 1st day of each cycle), then 6mg/kg once every 3 weeks, totaling 6 cycles

DRUG

Docetaxel

Docetaxel: injection; dose 75mg/m2, 75mg/m2 once every 3 weeks (intravenous infusion, not less than 60 minutes, on the 1st day of each cycle), totaling 6 cycles;

DRUG

Carboplatin

Carboplatin: injection; dose AUC6, AUC6 once every 3 weeks (intravenous infusion, not less than 30 minutes, on the 1st day of each cycle), totaling 6 cycles;

Trial Locations (1)

200032

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
collaborator

Fudan University

OTHER

lead

Shanghai Institute Of Biological Products

INDUSTRY

NCT03989037 - A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer | Biotech Hunter | Biotech Hunter