RecruitingPhase 2NCT07180082
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer
Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer: a Prospective, Randomized, Controlled, Multicentre Clinical Trial
Sponsor
Wenjin Yin
Enrollment
186 participants
Start Date
Aug 28, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria2
- During pregnancy and lactation
- Difficulties with pyrotinib administration or absorption
Interventions
DRUGPyrotinib
anti-HER2 tyrosine kinase inhibitor
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07180082
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