Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
ConditionLocally Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorRenJi Hospital
About this trial
This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.
Eligibility criteria
Qualifiers
Female, Aged ≥18 and ≤70 years;
Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;
Completed neoadjuvant therapy, including chemotherapy and trastuzumab;
Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;
Disqualifiers
Metastatic disease (Stage IV) ;
Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
Progressive disease during neoadjuvant therapy;
Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
Trial design
Treatments tested in this trial
- pyrotinib
Treatment groups
316 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov