The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.
Histologically confirmed invasive breast cancer;
Clinical stage (assessed by mammography or MRI): T0-4 (including inflammatory breast cancer), N1-3, M0; or ≥ T3, N0, M0 (according to AJCC 8th edition);
HER2-positive as determined by the central laboratory, defined as IHC 3+ or IHC 2+ and ISH-positive;
For unifocal and multifocal tumors (i.e., more than one tumor, all confined to the same quadrant as the primary tumor), at least 1 lesion should be sampled and confirmed as HER2-positive by the central laboratory;
1. Past medical history of invasive breast carcinoma. 2. Stage IV (metastatic) breast cancer (per AJCC 8th edition). 3. History of any second malignancy within 3 years prior to signing the ICF, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.
Any previous and current heart failure or systolic dysfunction meeting the NYHA criteria;
High-risk uncontrollable arrhythmia: atrial tachycardia with resting heart rate > 100 beats/min, significant ventricular arrhythmia (such as ventricular tachycardia), or high-grade atrioventricular block (such as Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);
Unstable angina or angina requiring antianginal medication
Parallel
HLX87+HX22
DrugHLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. HLX22 is a novel monoclonal antibody targeting HER2
HLX87 + Pertuzumab
DrugHLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan.
TCbHP
DrugDocetaxel +Carboplatin+Trastuzumab+Pertuzumab+
• Total pathologic complete response (tpCR) rate
as assessed by the Independent Review Committee (IRC). tpCR is defined as the absence of histological evidence of malignancy in both the primary lesion of breast cancer and regional lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 8th edition).
• tpCR rate assessed by the study site
• Breast pathologic complete response (bpCR) rate
Objective response rate (ORR)
Incidence and severity of adverse events (AEs)
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This trial is not recruiting at the moment. You can still explore other options:
