Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer
ConditionBreast Cancer Invasive
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital
About this trial
This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Eligibility criteria
Qualifiers
Aged ≥18;
Histologically confirmed invasive HER2 positive breast cancer;
Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
Disqualifiers
Metastatic disease (Stage IV);
Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
Treated or treating with anti-HER2 tyrosine kinase inhibitor;
Trial design
Treatments tested in this trial
- pyrotinib
Treatment groups
488 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov