A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Women aged 18 to 75 (inclusive)
• HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology.
• ECOG score is 0 or 1
• An expected survival of ≥ 12 weeks
• At least one measurable lesion according to RECIST v1.1 criteria
• Have adequate renal and hepatic function
• Patients voluntarily joined the study and signed informed consent
Locations
Other Locations
China
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Qi Zhang
qi.zhang@hengrui.com
+0518-81220121
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2032-10
Participants
Target number of participants: 864
Treatments
Experimental: Treatment group A: SHR-A1811 Injection
Experimental: Treatment group B: SHR-A1811 Injection and Pertuzumab Injection
Active_comparator: Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection
Related Therapeutic Areas
Sponsors
Leads: Jiangsu HengRui Medicine Co., Ltd.