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NOT YET RECRUITING
NCT07528716
PHASE3

Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

Based on total pathologic complete response (tpCR) after surgery, to evaluate the efficacy of an artificial intelligence model-matched anti-HER2 targeted treatment strategy (investigational arm) versus nab-paclitaxel + carboplatin + trastuzumab + pertuzumab (PCbHP, control arm) as neoadjuvant therapy for patients with early or locally advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Official title: Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy: A Randomized, Controlled, Open-Label, Multicenter Phase III Clinical Study

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2026-05

Completion Date

2028-06

Last Updated

2026-04-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

SHR- A1811

the experimental group consists of different neoadjuvant treatment regimens matched by the artificial intelligence model

DRUG

PCbHP

Standard neoadjuvant treatment regimen for HER2-positive breast cancer

DRUG

SHR- A1811+ Pyrotinib

the investigational arm consists of different neoadjuvant treatment regimens matched by the artificial intelligence model

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China