Recruiting

ctDNA in HER2+ EBC Neoadjuvant Treatment

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

ClinicalTrials.gov IDNCT07335081

PhasePHASE2

Enrollment60

SponsorShanghai Jiao Tong University School of Medicine

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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

Primary outcomes

ctDNA clearance after one cycle neoadjuvant treatment (3 months after neoadjuvant treatment initation)

Eligibility information

Inclusion Criteria: * histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter \>2cm) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography * No prior treatment Exclusion Criteria: * Bilateral or metastatic breast cancer * History of other malignancies * Severe cardiovascular disease * Allergic to any of the regimens

Study locations

Ruijin Hospital, Shanghai, 200025 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.