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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Haoyu Wang
meredithwhy@163.com
86 18817865256
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Pyrotinib-initiated arm
two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab
Active_comparator: Pertuzumab-initiated arm
four cycles of docetaxel + trastuzumab + pertuzumab
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine