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NOT YET RECRUITING
NCT07844291
NA

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

View on ClinicalTrials.gov

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

Interventions

DRUG

A1811

Switch to A1811 therapy for 4 cycles

DRUG

THP

Continue the THP regimen for 4 cycles