Actively Recruiting
Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-04-29
112
Participants Needed
9
Research Sites
202 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients.
CONDITIONS
Official Title
Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years old
- Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0)
- HER2 overexpression defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification by fluorescence in situ hybridization (FISH)
- Baseline left ventricular ejection fraction (LVEF) of 50% or higher
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Adequate major organ function with no blood transfusion or use of blood cell–raising drugs within 2 weeks before first dose
- Absolute neutrophil count of 1,500/mcL or higher
- Platelets 100,000/mcL or higher
- Hemoglobin 9.0 g/dL or higher
- Total bilirubin 1.5 times the upper limit of normal (ULN) or less
- Alanine aminotransferase and aspartate aminotransferase (ALT/AST) 1.5 times ULN or less
- Blood urea nitrogen and serum creatinine 1.5 times ULN or less
- Creatinine clearance 50 ml/min or higher (Cockcroft-Gault formula)
- Signed informed consent
You will not qualify if you...
- History of invasive breast cancer, bilateral breast cancer, or inflammatory breast cancer
- Prior excisional or incisional biopsy of the primary tumor or axillary lymph nodes
- Prior systemic therapy for breast cancer
- History of life-threatening hypersensitivity or known allergy to any study drug component
- Participation in another clinical trial within 4 weeks before first dose or receipt of investigational drug/device during trial
- Major surgery within 28 days before first dose or planned major surgery during study
- History of other cancers within past 5 years except certain in situ or localized cancers
- Active tuberculosis or serious infections requiring systemic treatment
- History of immunodeficiency or autoimmune diseases including HIV, lupus, rheumatoid arthritis, or organ transplantation
- History of cardiovascular or cerebrovascular diseases such as unstable angina, significant arrhythmias, recent myocardial infarction, heart failure, advanced heart block, or recent stroke
- Poorly controlled hypertension or history of hypertensive crisis or encephalopathy
- Unsuitability for oral drug administration due to gastrointestinal diseases or conditions affecting drug absorption
- Pregnant or breastfeeding women or women unwilling to use effective contraception during study and for 6 months after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Guangdong Women and children Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
3
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Actively Recruiting
4
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Not Yet Recruiting
5
Guangxi Provincial Cancer Hospital
Nanning, Guangxi, China
Not Yet Recruiting
6
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Not Yet Recruiting
7
Hainan Central Hospital
Haikou, Hainan, China
Not Yet Recruiting
8
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Not Yet Recruiting
9
Peking University Shenzhen Hospita
Shenzhen, China
Not Yet Recruiting
Research Team
Q
Qiang Liu, PhD
CONTACT
Y
Yudong Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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