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Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer

Study acronym: ATP
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 11, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Re-verified, no change to tracked fieldsv5
  2. Notable Primary completion date: Aug 2023 to Aug 2026v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2020 to Dec 16, 2019
    • Site details revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
190 trials monitored
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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 Number NCT04254263
Lead Sponsor RenJi Hospital
Conditions
(from sponsor)
Locally Advanced Breast Cancer
Enrollment 316 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov