Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

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.

Trial Details

NCT ID
NCT04254263
Phase
PHASE3
Sponsor
RenJi Hospital
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • pyrotinib
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • 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 neoadjuvan…

For full eligibility, visit ClinicalTrials.gov.

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