Clinical Trial

Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Study acronym: ATP
Recruiting Phase 3
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-02-01; most recent amendment 2025-09-10.
Status change: Not Yet Recruiting → Recruiting 2022-04-19
Trial Details
NCT Number NCT04254263
Lead Sponsor RenJi Hospital
Conditions Locally Advanced Breast Cancer
Enrollment 316 participants
Start Date 2019-12-16
Primary Completion 2026-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2025-09-11