Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

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

Inclusion Criteria:

* 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 Criteria:

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

Conditions3

Interventions1

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