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Recruiting NCT07335081

ctDNA in HER2+ EBC Neoadjuvant Treatment

Phase II Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pyrotinib, pertuzumab, trastuzumab, docetaxel.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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 outcome measures

  • ctDNA clearance after one cycle neoadjuvant treatment [Time frame: 3 months after neoadjuvant treatment initation]
Secondary outcome measures (7)
  • ctDNA clearance after two cycle neoadjuvant treatment [Time frame: 3 months after neoadjuvant treatment initation]
  • pCR rate [Time frame: 6 months after neoadjuvant treatment initation]
  • bpCR rate [Time frame: 6 months after neoadjuvant treatment initation]
  • ORR [Time frame: 6 months after neoadjuvant treatment initation]
  • EFS [Time frame: 2 years after surgery]
  • DFS [Time frame: 2 years after surgery]
  • OS [Time frame: 5 years after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Ruijin Hospital — Shanghai

Identifiers

NCT: NCT07335081 · RJBC2401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗