Clinical Trial

Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer

Not Yet Recruiting Phase 2
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Summary
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.
Trial Details
NCT Number NCT07416253
Lead Sponsor Henan Cancer Hospital
Conditions Breast Cancer
Enrollment 68 participants
Start Date 2026-03
Primary Completion 2027-03 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-18