drugset
drugset / Trial / NCT07335081

ctDNA in HER2+ EBC Neoadjuvant Treatment

NCT07335081 ↗

Phase 2 Recruiting 60 enrolled Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy

Timeline

Start
2024-02-01
Primary completion
2025-12-31
Completion
2026-12-31

Drugs

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

Indications

breast cancer