NCT07335081

ctDNA in HER2+ EBC Neoadjuvant Treatment

A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	pyrotinib	pyrotinib 320mg p.o. qd
DRUG	pertuzumab	pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
DRUG	trastuzumab	trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
DRUG	docetaxel	docetaxel ivgtt q3w, 80-100mg/m2

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2026-01-12
• Last updated: 2026-03-24

Locations

1 site across 1 country: China