ctDNA in HER2+ EBC Neoadjuvant Treatment
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
Shanghai Jiao Tong University School of Medicine
60 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria4
- Bilateral or metastatic breast cancer
- History of other malignancies
- Severe cardiovascular disease
- Allergic to any of the regimens
Interventions
pyrotinib 320mg p.o. qd
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
docetaxel ivgtt q3w, 80-100mg/m2
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07335081