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

Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd.
Study ID
NCT06107790
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HS022 — DRUG
    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
  • Trastuzumab — DRUG
    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
  • Vinorelbine Bitartrate — DRUG
    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.

Study Details

This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety and Immunogenicity of Vinorelbine Bitartrate Injection in Combination With HS022 and Trastuzumab®.There were 2 parts. Part 1 needs 8 treatment cycles ( at least 24 weeks); Part2 needs 9 treatment cycles (at least 27 weeks).

Key Dates

Start date
May 16, 2018
Status verified
Sep 2023
Primary completion
Jan 28, 2022
Completion
Jan 28, 2022

Study Design

Enrollment
570 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HS022+ Vinorelbine Bitartrate
  • Active Comparator: Trastuzumab®+ Vinorelbine Bitartrate Injection

Primary Outcome Measure

ORR [ Time Frame: WEEK 25 ]

Related Studies