Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China, 200127
Actively Recruiting
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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