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A Prospective, Open-label, Randomized Trial Comparing Switch to A1811 Versus Continued THP Neoadjuvant Therapy After THP Induction in HER2-Positive Breast Cancer
Sponsor: Peking University People's Hospital
Summary
This is a multicenter, open-label, randomized controlled trial. A total of 432 eligible patients with HER2-positive breast cancer will be enrolled after screening. All patients will receive THP-based neoadjuvant therapy (THP) for 2 cycles. After 2 cycles, imaging-based response will be assessed according to RECIST v1.1. Patients with a response or stable disease (PR or SD) will be randomized 1:1 into the experimental group or the control group. Randomization occurs after the 2-cycle assessment. Experimental group: Switch to A1811 therapy for 4 cycles. Control group: Continue the THP regimen for 4 cycles. After completing a total of 6 cycles of neoadjuvant therapy, all patients will undergo definitive surgical treatment for pathological assessment. Primary endpoint: Pathologic complete response (pCR).
Official title: Switching to A1811 vs. Continuation of the Original Neoadjuvant Regimen After THP Induction in HER2-Positive Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
432
Start Date
2026-11-01
Completion Date
2031-12-31
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
A1811
Switch to A1811 therapy for 4 cycles
THP
Continue the THP regimen for 4 cycles