Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer: a Prospective, Randomized, Controlled, Multicentre Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of continuous versus intermittent pyrotinib therapy in patients with human epidermal growth factor receptor (HER2)-positive advanced breast cancer.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age≥18 years old
• Pathologically confirmed advanced or locally advanced breast cancer not amenable to curative surgery
• Pathologically confirmed HER2+ at least once for either primary or metastatic lesion
• Previously treated with any number of lines for advanced disease and eligible for a pyrotinib-containing regimen at the discretion of physician
• At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
• ECOG 0-1
• Adequate organ function
Locations
Other Locations
China
Renji Hospital, School of Medicine, Shanghai Jiaotong University
RECRUITING
Shanghai
Contact Information
Primary
Wenjin Yin, M.D.
yinwenjin@renji.com
86(21)68385569
Backup
Yin
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2029-09
Participants
Target number of participants: 186
Treatments
Experimental: Intermittent pyrotinib
Intermittent use of pyrotinib, 14 days on and 7 days of, every 21 days
Active_comparator: Continuous pyroitnib
oral pyrotinib qd
Related Therapeutic Areas
Sponsors
Leads: Wenjin Yin