Actively Recruiting
Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-09-25
300
Participants Needed
1
Research Sites
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neratinib is an irreversible pan-HER tyrosine kinase inhibitor (TKI). Currently, no studies have investigated the use of macromolecular anti-HER2 agents combined with TKIs for the treatment of non-pCR HER2-positive breast cancer following neoadjuvant therapy. Furthermore, there are no prospective randomized controlled trials comparing trastuzumab plus pertuzumab versus trastuzumab plus TKIs in HER2-positive breast cancer patients with residual cancer burden class (RCB) I or II after neoadjuvant trastuzumab and pertuzumab. Therefore, this study aimed to evaluate the efficacy and safety of adjuvant trastuzumab plus neratinib in patients with hormone receptor-positive/HER2-positive breast cancer and RCB 0/I following neoadjuvant trastuzumab and pertuzumab therapy.
CONDITIONS
Official 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 diagnosis, including cT1mi/N0 or cT1a-b/N0
- Histologically confirmed hormone receptor-positive (estrogen receptor 3 or progesterone receptor 3) and HER2-positive invasive breast cancer
- Completed at least 4 cycles of neoadjuvant trastuzumab and pertuzumab therapy without recurrence or metastasis before adjuvant treatment
- Residual cancer burden class 0 or I after neoadjuvant therapy
- Time from initial surgery to randomization within 12 weeks
- Adequate organ function within 2 weeks prior to screening: absolute neutrophil count 1.5 109/L, platelet count 9 109/L, hemoglobin 9 g/L, total bilirubin 1.5 times upper limit of normal, alanine aminotransferase and aspartate aminotransferase 1.5 times upper limit of normal
- Left ventricular ejection fraction 5% or higher during screening, with no more than 15% decrease from pre-chemotherapy levels
- Life expectancy of 6 months or longer
- Agreement to use effective non-hormonal contraception or abstain from sexual activity during treatment and for 8 weeks after last dose if premenopausal or not sterilized
- Willingness to provide informed consent and comply with study requirements
You will not qualify if you...
- History of local or regional breast cancer recurrence
- Clinical stage IV (metastatic) breast cancer
- Bilateral breast cancer
- History of other cancers within past 5 years, except treated cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma
- Prior treatment with pyrotinib, lapatinib, neratinib, other tyrosine kinase inhibitors, trastuzumab emtansine, or any antitumor biological or immunotherapy
- Concurrent participation in another clinical trial involving antitumor therapy
- Significant cardiac disease including heart failure, systolic dysfunction (LVEF < 50%), poorly controlled arrhythmias, angina requiring medication, significant valvular disease, evidence of myocardial infarction, or poorly controlled 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 or history of immunodeficiency or organ transplantation
- Pregnancy, lactation, or positive pregnancy test at baseline
- Severe comorbidities interfering with treatment or active infections such as hepatitis B, hepatitis C, tuberculosis, or syphilis
AI-Screening
AI-Powered Screening
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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
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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