Clinical Trial

This Study Aims to Optimize Neoadjuvant Therapy for HER2-positive Breast Cancer by Implementing a Dynamic Monitoring-guided Treatment Strategy.

Study acronym: HER2-DM-NACT
Not Yet Recruiting Phase 2
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Summary
This study aims to optimize neoadjuvant therapy for HER2-positive breast cancer by implementing a dynamic monitoring-guided treatment strategy. Patients will initially receive trastuzumab, pyrotinib, and albumin-bound paclitaxel. Those who do not achieve a radiological response after Cycle 2 will switch to SHR-A1811 (a HER2-targeted antibody-drug conjugate) combined with pertuzumab. The primary objective is to evaluate whether this sequential treatment strategy improves the pathological complete response (pCR) rate while maintaining safety. The study will also explore the value of dynamic efficacy monitoring in guiding treatment adjustments and assess the safety and tolerability of the regimens.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-07.
Trial Details
NCT Number NCT06973525
Lead Sponsor Hebei Medical University Fourth Hospital
Conditions HER2-positive Breast Cancer
Enrollment 30 participants
Start Date 2025-09-01
Primary Completion 2027-05-31 (estimated)
Study Completion 2032-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-05