Actively Recruiting
SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
Led by Henan Cancer Hospital · Updated on 2025-06-23
180
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are: * Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment? * Is the safety of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? Researchers will compare SHR-A1811+pertuzumab or SHR-A1811+pertuzumab+albumin-paclitaxel to TCbHP to see if SHR-A1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced HER2-positive breast cancer. Subjects will be randomly assigned 1:1:1 to： * cohort 1：SHR-A1811 combined with pertuzumab for 6 cycles; * cohort 2：SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles; * cohort 3：TCbHP (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
CONDITIONS
Official Title
SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years with ECOG performance status 0-1
- Clinical stage T2 to T4 breast cancer with any lymph node involvement and no distant metastasis (M0)
- HER2-positive invasive breast cancer confirmed by pathology
- Measurable tumor lesions visible on ultrasound, mammography, or optional MRI within one month before randomization
- Adequate organ and bone marrow function within one month before chemotherapy
- Left ventricular ejection fraction (LVEF) of at least 50% by cardiac ultrasound
- Negative serum pregnancy test for women of childbearing age within 7 days before randomization
- Signed informed consent form
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- Prior chemotherapy, endocrine therapy, targeted therapy, or reflex therapy for this breast cancer
- Second primary malignant tumor except fully treated skin cancer
- Major surgery unrelated to breast cancer within 4 weeks before enrollment or not fully recovered from such surgery
- Uncontrolled cardiovascular or cerebrovascular diseases within 6 months before first dose, including severe heart failure, heart attack, stroke, pulmonary embolism, unstable angina, or arrhythmia requiring treatment
- Primary cardiomyopathy or significant heart rhythm disorders
- Unmanageable hypertension judged unsuitable for study
- Serious, uncontrollable medical diseases contraindicating chemotherapy
- Known allergies to study drugs
- History of immunodeficiency diseases, positive HIV test, or prior organ transplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Z
Zhenzhen Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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