This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles. After completing neoadjuvant treatment, patients will undergo definitive surgery, and tpCR will be assessed from resected specimens. Patients will then be followed up to monitor long-term efficacy (e.g., EFS) and late-onset adverse events. A total of 68 patients (34 per arm) will be enrolled to achieve the study's statistical objectives.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Participants will receive Trastuzumab-rezetecan for 8 cycles
Participants will receive Trastuzumab deruxtecan for 8 cycles
Pathological Complete Response Rate
Time frame: 3 to 8 weeks after neoadjuvant treatment completion
3-Year Event-Free Survival (EFS) Rate
Time frame: 3 years after randomization
Objective Response Rate (ORR)
Time frame: Within 6 months after randomization
Event-Free Survival (EFS)
Time frame: 5-10 years
EORTC QLQ-C30
Time frame: Within 1 year after randomization
QLQ-BR23
Time frame: within 1 year after randomization
Adverse enents
Time frame: First dose to 30 days after last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.