Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer

This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After receiving neoadjuvant dual-HER2-targeted therapy with chemotherapy, patients are evaluated for their treatment response. Those achieving an adequate response continue the therapy, whereas patients with a suboptimal response transition to an intensified investigational regimen incorporating novel targeted agents. This adaptive approach aims to optimize pathologic response, minimize unne

Trial Details

NCT ID

NCT07340398

Phase

PHASE2

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

RECRUITING

Cancer Type

HER2 Positive Breast Cancer

Interventions

• Nab paclitaxel
• Carboplatin
• Trastuzumab
• Pertuzumab
• SHR-A1811
• Pyrotinib

Locations (sample)

• Hangzhou, China|30.29365,120.16142

Key Eligibility Criteria

• Age ≥18 and ≤75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Primary tumor size \>1 cm.
• Histologically confirmed invasive breast cancer, clinically staged as:

For full eligibility, visit ClinicalTrials.gov.

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