Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT03084237
- Lead Sponsor
- Shanghai Henlius Biotech
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 652
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Herceptin®+Docetaxel Herceptin® Herceptin®+Docetaxel Herceptin®+Docetaxel docetaxel Herceptin®+Docetaxel HLX02+Docetaxel HLX02 HLX02+Docetaxel HLX02+Docetaxel docetaxel HLX02+Docetaxel
- Primary Outcome Measures
Name Time Method ORR 24 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 Outcome Measures
Name Time Method DoR Up to 2 years The time from first documentation of CR or PR to the first documentation of progression.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)，At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or Unequivocal progression of existing non-target lesions (Note: the appearance of one or more new lesions is also considered progression).DCR Up to 2 years The percentage of patients who achieve CR, PR, or stable disease (SD) of at least 12 weeks
CBR Up to 2 years The proportion of patients who achieve CR, PR, or durable SD (SD ≥24 weeks)
Median PFS up to 12 Months From time of first treatment to 12 months Median Progression Survival time assessed at 12 months.The probability of being alive without documented progression up to 12 months after randomization.
Overall Survival at 12, 24, and 36 Months From time of first treatment to 36 months the probability of being alive 12, 24, and 36 months after randomization
Trial Locations
- Locations (88)
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Guangzhou University of TMC
🇨🇳Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Scroll for more (78 remaining)The First Affiliated Hospital of Anhui Medical University🇨🇳Hefei, Anhui, China