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

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT06973525
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    Drug: SHR-A1811 Drug: Pertuzumab
  • 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. — 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.

Study Details

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.

Key Dates

First listed
May 15, 2025
Start date
Sep 1, 2025
Status verified
May 2025
Primary completion
May 31, 2027
Completion
May 31, 2032

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-A1811+Pertuzumab
    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.
  • Active Comparator: trastuzumab, pyrotinib, and nab-paclitaxe
    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.

Primary Outcome Measure

tpCR [ Time Frame: At the time of surgery ]

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