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ctDNA in HER2+ EBC Neoadjuvant Treatment

NCT07335081 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07335081 on ClinicalTrials.gov