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RECRUITING
NCT07335081
PHASE2

ctDNA in HER2+ EBC Neoadjuvant Treatment

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-02-01

Completion Date

2026-12-31

Last Updated

2026-03-24

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Ruijin Hospital

Shanghai, China