Actively Recruiting
Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy
Led by RenJi Hospital · Updated on 2025-09-11
316
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pyrotinib as an additional treatment for women with residual invasive HER2-positive breast cancer after they have received neoadjuvant chemotherapy combined with anti-HER2 therapies. This Phase 3, prospective, randomized, multicenter, open-label study aims to determine if pyrotinib can further reduce the risk of cancer recurrence beyond the standard one-year trastuzumab treatment with or without pertuzumab. Participants are randomly assigned to one of two groups: one group receives pyrotinib 400 mg orally once daily for one year along with trastuzumab, while the other group undergoes observation follow-up without pyrotinib. The study does not use a placebo control, and treatment assignment is open to both researchers and participants. During the study, participants will be monitored for invasive disease-free survival up to two years from randomization. Researchers will also assess disease-free survival and overall survival within the same timeframe. Safety will be evaluated throughout the study, and participants will be followed for adverse events and response outcomes. The trial is sponsored by RenJi Hospital and involves women aged 18 to 70 years who meet specific health and treatment criteria.
CONDITIONS
Brief Title
Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 70 years
- Histologically confirmed invasive HER2-positive breast cancer, early stage (Stage IA-II)
- Completed neoadjuvant chemotherapy and trastuzumab
- Residual invasive disease detected in breast or axillary lymph nodes after neoadjuvant chemotherapy
- Treated or being treated for early breast cancer with standard trastuzumab duration
- Adjuvant treatment plan determined before randomization
- Time from last trastuzumab use to randomization is 1 year or less
- ECOG performance status 0 or 1
- Required laboratory values within specified ranges including ANC, platelets, hemoglobin, liver and kidney function, LVEF ≥ 50%, QTcF < 470 ms
- Signed informed consent form
You will not qualify if you...
- Metastatic disease (Stage IV)
- Gross residual disease after mastectomy or positive margins after breast-conserving surgery
- Progressive disease during neoadjuvant therapy
- Unable to swallow tablets or with gastrointestinal absorption issues
- Treated or currently treating with anti-HER2 tyrosine kinase inhibitors such as pyrotinib, lapatinib, or neratinib
- Less than 4 weeks since last clinical trial participation
- History of immunodeficiency including HIV, or history of organ transplantation
- History of heart disease including angina, significant arrhythmia, myocardial infarction, heart failure, or other heart conditions judged unsuitable
- Pregnant, lactating, or women of childbearing potential testing positive for pregnancy or unwilling to use contraception
- Significant medical illnesses increasing risk for study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants receive pyrotinib 400 mg orally once daily for one year or are observed without pyrotinib.
Regular visits during treatment as per study protocol
Trial Site Locations
Total: 1 location
1
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
W
Wenjin Yin
Q
Qi Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here