Actively Recruiting
A Randomized, Open-Label Trial Comparing Adjuvant Trastuzumab Plus Neratinib Versus Trastuzumab Plus Pertuzumab in Hormone Receptor-Positive/HER2-Positive Breast Cancer With Residual Cancer Burden 0/I After Neoadjuvant Therapy
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-09-25
300
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of adding neratinib, an irreversible pan-HER tyrosine kinase inhibitor, to trastuzumab as adjuvant therapy in women with hormone receptor-positive and HER2-positive breast cancer. This study focuses on patients who have residual cancer burden class 0 or I after completing neoadjuvant therapy with trastuzumab and pertuzumab, as there are currently no prospective randomized trials comparing trastuzumab plus pertuzumab versus trastuzumab plus tyrosine kinase inhibitors in this group. Participants will be randomly assigned to receive either trastuzumab combined with pertuzumab or trastuzumab combined with neratinib. Trastuzumab is given intravenously every 3 weeks for a total of 18 cycles covering both preoperative and adjuvant phases. Pertuzumab is administered intravenously with a loading dose followed by maintenance doses every 3 weeks, while neratinib is taken orally daily during the adjuvant period. During the 3 years following random assignment, researchers will monitor invasive disease-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, distant disease-free survival, and the incidence and severity of adverse events. Participants will undergo assessments including echocardiography to monitor heart function and laboratory tests to ensure organ function. The study lasts for several years, with safety and treatment effects closely followed.
CONDITIONS
Brief Title
Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Clinical stage cT1-4/N1-3/M0 at initial diagnosis; cT1mi/N0 or cT1a-b/N0 also eligible
- Histologically confirmed hormone receptor-positive (estrogen receptor 61;1% and/or progesterone receptor 61;1%) and HER2-positive invasive breast cancer
- Completed at least 4 cycles of neoadjuvant trastuzumab and pertuzumab without recurrence or metastasis before adjuvant treatment
- Residual cancer burden class 0 or I after neoadjuvant therapy
- Time from initial surgery to randomization less than or equal to 12 weeks
- Adequate organ function within 2 weeks before screening (with specified blood counts and liver enzyme limits)
- Left ventricular ejection fraction (LVEF) 61;50% at screening with less than 15% decrease from pre-chemotherapy; or LVEF 61;55% if no pre-chemotherapy assessment
- Life expectancy of at least 6 months
- Agreement to abstain from sexual activity or use effective non-hormonal contraception during treatment and for 8 weeks after last dose if premenopausal or non-sterilized
- Willingness to participate voluntarily, provide informed consent, and comply with study procedures
You will not qualify if you...
- History of local or regional breast cancer recurrence
- Clinical stage IV (metastatic) breast cancer
- Bilateral breast cancer
- Other malignant tumors within past 5 years except certain treated cancers
- Prior treatment with tyrosine kinase inhibitors like pyrotinib, lapatinib, neratinib, trastuzumab emtansine, or other antitumor biological or immunotherapy
- Concurrent participation in another clinical trial involving antitumor therapy
- Significant cardiac disease including heart failure, poor arrhythmias, angina, valvular disease, prior myocardial infarction, or uncontrolled hypertension
- Impaired drug absorption due to gastrointestinal disorders
- History of neurological or psychiatric conditions affecting compliance or consent
- Chronic gastrointestinal disorders with predominant diarrhea
- Known hypersensitivity to study drugs, history of immunodeficiency, or organ transplantation
- Pregnancy, lactation, or positive pregnancy test at baseline
- Severe comorbidities or active infections that may interfere with treatment or study participation
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) for eligibility assessments including blood tests and heart function evaluation
Duration - Up to 18 cycles of treatment, each cycle lasting 3 weeks
Participants receive adjuvant treatment with trastuzumab combined with either neratinib or pertuzumab following neoadjuvant therapy.
Infusions every 3 weeks with daily oral medication if assigned to neratinib; visits aligned with each treatment cycle
Duration - Up to 3 years after random assignment
Participants are monitored for invasive disease free survival, overall survival, and adverse events after completing adjuvant treatment.
Periodic follow-up visits during the 3 years after treatment completion
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Sun Yat-sen Memorial Hospital
Guangzhou, China
Actively Recruiting
Research Team
C
Chang Gong
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