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Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy

NCT07528716 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-04-14

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528716 on ClinicalTrials.gov