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ctDNA in HER2+ EBC Neoadjuvant Treatment

ctDNA in HER2+ EBC Neoadjuvant Treatment

Recruiting
18-70 years
Female
Phase 2
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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

Eligibility

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 details
    Breast Cancer

NCT07335081

Shanghai Jiao Tong University School of Medicine

1 February 2026

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