A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Voluntarily enrolled in this study and signed an informed consent form (ICF).
• Age ≥ 18 years.
• Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
• Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
• No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
• Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1.
• Presence of lesion (RECIST 1.1).
• Adequate organ and bone marrow function
Locations
Other Locations
China
Clinical Trials Information Group
RECRUITING
Beijing
Contact Information
Primary
Clinical Trials Information Group Officer
ctr-contact@mail.ecspc.com
+86-0311-69085587
Backup
fenglin She
shefenglin@cspc.cn
18301190515
Time Frame
Start Date:2023-07-23
Estimated Completion Date:2027-12-31
Participants
Target number of participants:880
Treatments
Experimental: KN026+HB1801
Subjects will receive an intravenous (IV) infusion of KN026 plus HB1801. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurrs first.
On Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg/kg loading dose followed by 6 mg/kg per cycle, IV, D1, Q3W and docetaxel 75 mg/m\^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first.