Actively Recruiting
Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer
Led by RenJi Hospital · Updated on 2025-09-11
316
Participants Needed
1
Research Sites
450 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 disease (Stage IA-IIB)
- Completed neoadjuvant therapy including chemotherapy and trastuzumab
- Residual invasive disease found in breast or axillary lymph nodes after neoadjuvant chemotherapy
- Treated or being treated for early breast cancer with standard duration trastuzumab
- Adjuvant treatment plan determined before randomization
- Time from last trastuzumab use to randomization is 1 year or less
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Laboratory requirements: ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9.0 g/dL; Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 1.5 x ULN; BUN and creatinine clearance ≥ 50 mL/min; 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 have gastrointestinal absorption problems
- Current or prior treatment with anti-HER2 tyrosine kinase inhibitors including pyrotinib, lapatinib, or neratinib
- Less than 4 weeks since last clinical trial participation
- History of immunodeficiency including HIV, other acquired or congenital immunodeficiency, or organ transplantation
- History of heart disease including angina, significant arrhythmia requiring medication, myocardial infarction, heart failure, or other heart conditions deemed unsuitable by investigator
- Pregnancy, lactation, or positive pregnancy test at baseline; unwillingness to use effective contraception during trial
- Significant medical illnesses that increase risks for study participation as judged by investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
Q
Qi Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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