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Recruiting Phase 2

Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

About this study

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.

Condition
Advanced Breast Cancer
Tested
Pyrotinib
Sponsor
Wenjin Yin

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Study condition: Advanced Breast Cancer
  • 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 2

  • During pregnancy and lactation
  • Difficulties with pyrotinib administration or absorption

Where

1 site, 1 recruiting

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.