Patients with Stage II-III HER2-positive breast cancer will receive three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by imaging assessment. If clinical complete response (cCR) or radiological complete response/near radiological complete response (rCR/near rCR) is achieved, they will continue to receive an additional three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by surgery.
If cCR/rCR or near rCR is not achieved, the treatment will be switched to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.
Age and Gender: Female patients aged ≥18 years and ≤70 years. Histological Confirmation: Patients must have histologically confirmed invasive breast cancer and must not have received any prior systemic anti-tumor therapy for breast cancer.
HER2 Positivity: Histologically confirmed HER2 receptor positivity, following the 2018 ASCO-CAP HER2 positivity judgment guidelines.
Tumor Stage: Patients must have tumor staging conforming to the Stage II-III breast cancer criteria according to the eighth edition of the AJCC breast cancer TNM staging system (T1~T4, N1~N3, M0).
Measurable Target Lesion: At least one measurable target lesion according to RECIST V1.1.
Stage IV Breast Cancer: Patients with Stage IV breast cancer. Inflammatory Breast Cancer: Patients with inflammatory breast cancer. Prior Malignancy Treatment: Patients who have received prior anti-tumor therapy or radiotherapy for any malignancy, or have concurrent other malignancies, excluding cured cervical intraepithelial neoplasia, basal cell carcinoma, or squamous cell carcinoma.
Concurrent Anti-Tumor Therapy: Patients currently participating in other clinical trials involving anti-tumor therapy, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone modification therapy, or immune checkpoint inhibitor therapy.
Recent Surgery: Patients who have undergone major surgery unrelated to breast cancer within 4 weeks prior to the first dose of the study drug, or have not fully recovered from such surgery.
History of heart failure or systolic dysfunction (LVEF < 50%). Uncontrolled high-risk arrhythmia, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmia, or advanced atrioventricular block (i.e., Mobitz II second-degree or third-degree atrioventricular block).
Single group
Trastuzumab Deruxtecan
Drug4.8mg/kg, d1, q3w
Pertuzumab
Drug840mg on cycle1, 420mg on following cycles, d1, q3w
Taxane Chemotherapy
DrugNab-paclitaxel 100 mg per square meter, d1,d8,d15 q3w Or Paclitaxel 80mg per square meter, d1,d8,d15 q3w Or Docetaxel 100mg per square meter, d1 q3w
Trastuzumab (or biosimilar)
DrugTrastuzumab 8mg/kg (loading dose) or 6mg/kg on following cycles, d1, q3w
Pyrotinib 320mg
Drug320mg qd
pCR
ypT0/Tis ypN0
ORR
ORR per RECIST v1.1
EFS
Event free survival
OS
Overall survival
bpCR
ypT0/is
Incidence of Adverse events per NCI CTCAE 5.0
Safety per NCI CTCAE 5.0
Click on the lead sponsor to view all of their trials.
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Ruijin Hospital
Sponsor institution
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
