Continuous or Intermittent Pyrotinib for HER2-positive Advanced Breast Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWenjin Yin

About this trial

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 criteria

Qualifiers

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

Disqualifiers

During pregnancy and lactation

Difficulties with pyrotinib administration or absorption

Trial design

Treatments tested in this trial

  • Pyrotinib

Treatment groups

186 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Wenjin Yin

Lead sponsor

RenJi Hospital

Sponsor institution