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New treatment option for Early-stage Breast Cancer
Official title Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab
ClinicalTrials.gov ID: NCT05760612
What this study is testing
What is Trastuzumab and neratinib?
Trastuzumab and neratinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for early-stage breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Female patients aged 18-70 years;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Clinical stage at initial diagnosis (per the 8th edition of the American Joint Committee on Cancer Staging Manual): cT1-4/N1-3/M0 (cT1mi/N0 or...
- Histologically confirmed hormone receptor-positive (estrogen receptor ≥1% and/or progesterone receptor ≥1%) and HER2-positive (immunohistochemistry...
- Completion of ≥4 cycles of neoadjuvant therapy with trastuzumab and pertuzumab, without recurrence or metastatic disease prior to adjuvant treatment...
You likely can't join if
- History of local or regional breast cancer recurrence;
- Clinical stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- History of other malignant tumors within the past 5 years, except for curatively treated cervical carcinoma in situ, basal cell carcinoma, or...
- Prior treatment with pyrotinib, lapatinib, neratinib, or other tyrosine kinase inhibitors; trastuzumab emtansine; or any antitumor biological or...
- Concurrent participation in another clinical trial involving antitumor therapy, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
See the full eligibility criteria
- Female patients aged 18-70 years;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
- Clinical stage at initial diagnosis (per the 8th edition of the American Joint Committee on Cancer Staging Manual): cT1-4/N1-3/M0 (cT1mi/N0 or cT1a-b/N0 are eligible), meeting the criteria for neoadjuvant therapy as per...
- Histologically confirmed hormone receptor-positive (estrogen receptor ≥1% and/or progesterone receptor ≥1%) and HER2-positive (immunohistochemistry 3+ or fluorescence in situ hybridization-positive) invasive breast...
- Completion of ≥4 cycles of neoadjuvant therapy with trastuzumab and pertuzumab, without recurrence or metastatic disease prior to adjuvant treatment; residual cancer burden class 0 or I after neoadjuvant therapy; time...
- Adequate organ function within 2 weeks prior to screening (without transfusion or use of growth factors):
- Absolute neutrophil count ≥1.5 × 10⁹/L;
- Platelet count ≥90 × 10⁹/L;
- Hemoglobin ≥90 g/L;
- Total bilirubin ≤1.5 × upper limit of normal (ULN);
- Alanine aminotransferase and aspartate aminotransferase ≤1.5 × ULN;
- Post-neoadjuvant therapy echocardiography showing left ventricular ejection fraction (LVEF) ≥50% during screening, with an absolute decrease of ≤15% compared to pre-chemotherapy values; if no pre-chemotherapy LVEF...
- Life expectancy ≥6 months;
- For premenopausal or non-sterilized female patients: agreement to abstain from sexual activity or use effective non-hormonal contraception during study treatment and for 8 weeks after the last dose;
- Willingness to participate voluntarily, provide signed informed consent, demonstrate good compliance, and cooperate with follow-up.
- History of local or regional breast cancer recurrence;
- Clinical stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- History of other malignant tumors within the past 5 years, except for curatively treated cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma;
- Prior treatment with pyrotinib, lapatinib, neratinib, or other tyrosine kinase inhibitors; trastuzumab emtansine; or any antitumor biological or immunotherapy;
- Concurrent participation in another clinical trial involving antitumor therapy, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
- Significant cardiac disease, including:
- Heart failure or systolic dysfunction (LVEF \< 50%);
- Poorly controlled arrhythmias (e.g., atrial tachycardia, significant ventricular arrhythmia, or high-grade atrioventricular block);
- Angina requiring antianginal medication;
- Clinically significant valvular heart disease;
- Electrocardiographic evidence of transmural myocardial infarction;
- Poorly controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) despite medication;
- Impaired drug absorption due to dysphagia, intestinal obstruction, or other gastrointestinal disorders;
- History of neurological or psychiatric conditions that may compromise compliance or informed consent;
- Chronic gastrointestinal disorders with predominant diarrhea;
- Known hypersensitivity to any study drug components; history of immunodeficiency (e.g., HIV positivity, congenital or acquired immunodeficiency disorder), or prior organ transplantation;
- Pregnancy, lactation, or positive pregnancy test at baseline in women of childbearing potential;
- Severe comorbidities that may interfere with treatment, including active infections (e.g., hepatitis B, hepatitis C, tuberculosis, syphilis) or any other condition deemed by the investigator to render the patient...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.