Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

570

Participants

Timeline

Start Date

May 16, 2018

Primary Completion Date

January 28, 2022

Study Completion Date

January 28, 2022

Conditions
HER2-positive Breast Cancer
Interventions
DRUG

HS022

"8 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.~The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg"

DRUG

Trastuzumab

"8 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.~The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg"

DRUG

Vinorelbine Bitartrate

"Vinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). 3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.~Second section:9 treatment cycles, 3 weeks/cycle, 27 weeks. Vinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). The investigator may decide whether to continue treatment with vinorelbine at his discretion.~3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first."

Trial Locations (1)

210029

Jiangsu Province People's Hospital (First Affiliated Hospital of Nanjing Medical University), Nanjing

All Listed Sponsors
lead

Zhejiang Hisun Pharmaceutical Co. Ltd.

INDUSTRY

NCT06107790 - Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer | Biotech Hunter | Biotech Hunter