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Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

Recruiting
18 years and older
All
Phase 2
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Overview

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

Inclusion Criteria:

  • Ageā‰„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 Criteria:

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

Study details
    Advanced Breast Cancer

NCT07180082

Wenjin Yin

31 January 2026

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