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drugset / Trial / NCT07797218

Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC

NCT07797218 ↗

Phase 3 Recruiting 220 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.

Timeline

Start
2026-07-01
Primary completion
2028-06-30
Completion
2030-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule 320 mg Oral
Background Docetaxel Small molecule 80 mg/m2 Intravenous
Background Docetaxel Small molecule 100 mg/m2 Intravenous
Background Pertuzumab Monoclonal antibody 420 mg Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Trastuzumab Monoclonal antibody 600 mg Intravenous

Indications

breast cancer