RecruitingPhase 3NCT05910398

Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial


Sponsor

RenJi Hospital

Enrollment

488 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two schedules of a drug called pyrotinib — a targeted therapy for HER2-positive breast cancer — given after completing standard therapy: continuous daily dosing versus an intermittent schedule (taking breaks). The goal is to see which approach is more effective and better tolerated in the long term. **You may be eligible if...** - You are 18 or older - You have confirmed invasive HER2-positive breast cancer - You have completed treatment with trastuzumab or T-DM1 within the past 3 years - You are in good general health (ECOG 0–1) with adequate organ function **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (stage IV) - There is remaining tumor visible after surgery, or your surgical margins are positive - You cannot swallow tablets or have a condition preventing oral drug absorption - You have already received another anti-HER2 tyrosine kinase inhibitor (TKI) - You are pregnant, breastfeeding, or unwilling to use contraception - You have HIV, organ transplant history, or another immunodeficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpyrotinib

an irreversible anti-HER2 tyrosine kinase inhibitor


Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

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NCT05910398


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