This is a randomized, open label Phase II-III neoadjuvant study comparing the efficacy and safety of ARX788 combined with pyrotinib maleate versus TCBHP (trastuzumab plus pertuzumab with docetaxel and carboplatin) in patients with HER2-positive breast cancer.
This is a randomized, open label Phase II-III neoadjuvant study comparing the efficacy and safety of ARX788 combined with pyrotinib maleate versus TCBHP (trastuzumab plus pertuzumab with docetaxel and carboplatin) in patients with HER2-positive breast cancer. Patients will be randomized (1:1) to one of the two treatment arms: arm 1, ARX788 plus pyrotinib maleate for 6 cycles; arm 2, trastuzumab plus pertuzumab with docetaxel and carboplatin for six cycles. Patients will undergo surgery after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
HER2 antibody-drug conjugate
EGFR/HER2 dual inhibitor
anti-Her2 monoclonal antibody
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China
Total pathological complete response rate (tpCR) rate
The standard for removal of breast and lymph node tumors which means there are no infiltrating cancer cells at the primary breast and axillary lymph nodes, and only intraductal cancer is allowed on the breast.
Time frame: 3 years
Breast pathological complete response rate (bpCR) rate
The standard for breast tumor removal which means that there are only infiltrating cancer cells at the primary breast tumor site.
Time frame: 3 years
Residual tumor burden (RCB)
Postoperative pathological results will be used to assess the residual tumor area of primary breast tumor (area in mm×mm), the cell density of the residual tumor(cell density in percentages), the proportion of carcinoma in situ (proportion of carcinoma in percentages), the number of positive lymph nodes and the diameter of largest metastasis with residual nodes (diameter in mm). The RCB class can be estimated from the above five pathological parameters through a network calculation: RCB-0 in grades: pCR; RCB-I in grades: minimal residual tumor; RCB-II: moderate residual tumor; RCB-III in grades: extensive residual tumor.
Time frame: 3 years
Best overall response rate (BORR)
The proportion of patients who achieve remission at any point during the study.
Time frame: 3 years
Five-year overall survival (OS)
The time from the random date to death due to any cause.
Time frame: 5 years
Event-free survival (EFS)
The time from the day of enrollment to the first occurrence of recurrent disease, including second primary malignancies in the non-breast area and breast ductal carcinoma in situ.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
anti-HER2 monoclonal antibody
Cytotoxic chemotherapy
Cytotoxic chemotherapy
Time frame: 3 years
Adverse events (AE)
Adverse events (AE) will be assessed as per the NCI-CTC AE 5.0 standard.
Time frame: 3 years