ctDNA in HER2+ EBC Neoadjuvant Treatment

March 20, 2026 updated by: Kunwei Shen, Shanghai Jiao Tong University School of Medicine

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
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
Active Comparator: Pertuzumab-initiated arm
four cycles of docetaxel + trastuzumab + pertuzumab
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ctDNA clearance after one cycle neoadjuvant treatment
Time Frame: 3 months after neoadjuvant treatment initation
The rate of ctDNA clearance after first cycle of neoadjuvant treatment
3 months after neoadjuvant treatment initation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ctDNA clearance after two cycle neoadjuvant treatment
Time Frame: 3 months after neoadjuvant treatment initation
The rate of ctDNA clearance after first two cycles of neoadjuvant treatments
3 months after neoadjuvant treatment initation
pCR rate
Time Frame: 6 months after neoadjuvant treatment initation
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained mamtectomy samples and all ipsilateral lymph node samples
6 months after neoadjuvant treatment initation
bpCR rate
Time Frame: 6 months after neoadjuvant treatment initation
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples
6 months after neoadjuvant treatment initation
ORR
Time Frame: 6 months after neoadjuvant treatment initation
The proportion of patients whose tumor volume shrinks to a prespecified value and is able to maintain the minimum time limit, defined as the sum of the proportion of complete response (CR) and partial response (PR, with a reduction in tumor length and diameter greater than 30%).
6 months after neoadjuvant treatment initation
EFS
Time Frame: 2 years after surgery
The time interval from randomization to the first recording of the following events: disease progression (before surgery), as determined by investigator reference RECIST1.1, combined with clinical evaluation, final judgment; postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause
2 years after surgery
DFS
Time Frame: 2 years after surgery
The time interval from the first date of disease-free (i.e., the date of surgery) to the first recording of the following events; Postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause.
2 years after surgery
OS
Time Frame: 5 years after surgery
Time interval from randomization to death from any cause.
5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJBC2401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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