ctDNA in HER2+ EBC Neoadjuvant Treatment

NCT07335081 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Jiao Tong University School of Medicine

Phase

Phase 2

Started

2024-02-01

Last updated

2026-03-24

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

pyrotinib →pertuzumab →trastuzumab →docetaxel →

pyrotinib: pyrotinib 320mg p.o. qd

pertuzumab: pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance

trastuzumab: trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance

docetaxel: docetaxel ivgtt q3w, 80-100mg/m2

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

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

ctDNA clearance after one cycle neoadjuvant treatment — 3 months after neoadjuvant treatment initation
The rate of ctDNA clearance after first cycle of neoadjuvant treatment

Trial sites (1)

Facility	City	Region	Status
Ruijin Hospital	Shanghai	China	Recruiting

On this site

📄 Herceptin (trastuzumab) drug profile →

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Other trials for the same condition

A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors Recruiting

ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC Active, not recruiting

A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer Recruiting

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07335081 on ClinicalTrials.gov ↗ ← All trials in China