NCT03989037

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

A Phase III, Randomized, Single-blind Study Comparing the Efficacy, Safety, and Immunogenicity of SIBP-01 and CN-Trastuzumab Combination With Docetaxel and Carboplatin in Patients With Early or Locally Advanced Her2 Positive Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel and Carboplatin in patients with operable HER2 positive, with early or locally advanced HER2-positive breast cancer. The hypothesis to be tested in this study is the tpCR of patients with Cycle 6 of SIBP-01 is similar to CN-approved trastuzumab, using a 90% bilateral confidence interval between 0.74 and 1.5.

Conditions

• HER2-positive Early Breast Cancer

Interventions

Type	Name	Description
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;

Timeline

• Start date: 2019-06-27
• Primary completion: 2023-04-26
• Completion: 2023-04-26
• First posted: 2019-06-18
• Last updated: 2023-12-27

Locations

1 site across 1 country: China