NCT06973525

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

Optimizing Neoadjuvant Therapy for HER2-Positive Breast Cancer Based on Dynamic Efficacy Monitoring: A Trial of Trastuzumab Plus Pyrotinib and Albumin-Bound Paclitaxel Followed by SHR-A1811 Plus Pertuzumab（OnThePath Trial）

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hebei Medical University Fourth Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	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: SHR-A1811 Drug: Pertuzumab
DRUG	Patients will initially receive trastuzumab, pyrotinib, and nab-paclitaxel. Those who achieve a partial response (PR) or complete response (CR) after cycle 2 will continue on the same regimen.	Patients will initially receive trastuzumab, pyrotinib, and nab-paclitaxel. Those who achieve a partial response (PR) or complete response (CR) after cycle 2 will continue on the same regimen.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-05-31
• Completion: 2032-05-31
• First posted: 2025-05-15
• Last updated: 2025-08-05