Status:
RECRUITING
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
Lead Sponsor:
Wenjin Yin
Conditions:
Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- During pregnancy and lactation
- Difficulties with pyrotinib administration or absorption
Key Trial Info
Start Date :
August 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT07180082
Start Date
August 28 2025
End Date
September 1 2029
Last Update
November 18 2025
Active Locations (1)
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1
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China, 200127