Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05910398

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

Led by RenJi Hospital · Updated on 2025-11-18

488

Participants Needed

1

Research Sites

374 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Histologically confirmed invasive HER2 positive breast cancer
  • Time from randomization to last use of trastuzumab or T-DM1 is 3 years or less
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate organ functions
Not Eligible

You will not qualify if you...

  • Metastatic disease (Stage IV)
  • Gross residual disease after mastectomy or positive margins after breast-conserving surgery
  • Unable to swallow tablets or have gastrointestinal absorption problems
  • Currently treated or treated with anti-HER2 tyrosine kinase inhibitors
  • Less than 4 weeks since last clinical trial participation
  • History of immunodeficiency including HIV or organ transplantation
  • Female patients who are pregnant, lactating, or of childbearing potential with a positive pregnancy test or unwilling to use contraception
  • Significant medical illness increasing risk for study participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China, 200127

Actively Recruiting

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Research Team

W

Wenjin Yin, M.D.

CONTACT

Q

Qi Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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