Double-blind, Randomized, Multicenter, Phase III Clinical Study to Compare the Efficacy and to Evaluate the Safety and Immunogenicity of Trastuzumab Biosimilar HLX02 and EU-sourced Herceptin® in Previously Untreated HER2 Overexpressing Metastatic Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- HLX02
- Conditions
- Breast Cancer
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 652
- Locations
- 88
- Primary Endpoint
- ORR 24
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally recurrent or previously untreated metastatic breast cancer.
Detailed Description
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth factor receptor 2 (HER2)-positive, recurrent or previously untreated metastatic breast cancer. Eligible patients will be assessed centrally for HER2 status and the presence of at least one measurable target lesion before randomization. Patients will undergo a tumor assessment for evaluation of response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) every 6 weeks up to 24 weeks (regardless of the number of cycles actually given); thereafter, assessments will be done every 9 weeks (after Cycles 11, 14, and 17) or earlier in the case of clinical signs of progression.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
HLX02+Docetaxel
HLX02+Docetaxel
Intervention: HLX02
HLX02+Docetaxel
HLX02+Docetaxel
Intervention: docetaxel
Herceptin®+Docetaxel
Herceptin®+Docetaxel
Intervention: Herceptin®
Herceptin®+Docetaxel
Herceptin®+Docetaxel
Intervention: docetaxel
Outcomes
Primary Outcomes
ORR 24
Time Frame: From time of First treatment to week 24
calculated as the proportion of patients with a best response of complete response (CR) or partial response (PR) from first assessment until Week 24 according to RECIST 1.1 by central imaging review (CIR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions,Complete Response (CR): Disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to\<10 mm, Partial Response (PR): At least a 30% decrease in the sum ofdiameters of target lesions, taking as reference thebaseline sum diameters.Overall Response (OR) = CR + PR.
Secondary Outcomes
- DoR(Up to 2 years)
- DCR(Up to 2 years)
- CBR(Up to 2 years)
- Median PFS up to 12 Months(From time of first treatment to 12 months)
- Overall Survival at 12, 24, and 36 Months(From time of first treatment to 36 months)