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Research on AI Models for Predicting Breast Cancer Treatment Effectiveness to Guide Her-2 Targeted ADC Therapy

NCT07689929 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2026-07-08

No results posted yet for this study

Summary

This study aims to develop an AI-based predictive tool to help clinicians more accurately determine whether breast cancer patients can benefit from HER-2-targeted antibody-drug conjugate (T-DXd) therapy before treatment. While HER-2-targeted ADC drugs have significantly improved outcomes for patients with HER-2 positive and low-expression advanced breast cancer, there are notable individual differences in efficacy. Currently, there is a lack of precise clinical methods to predict response, which means some patients might receive ineffective treatment and face unnecessary drug side effects and financial burden.

This study is a retrospective multicenter observational study, planning to collect pathological images (including HE staining and HER-2, ER, PR, Ki-67 immunohistochemical staining), proteomics data, and clinical efficacy information from HER-2 positive and low-expression advanced breast cancer patients who have received T-DXd treatment.

The research will be carried out in five phases:

1. Build a clinical database for ADC drug therapy, integrating basic patient information, treatment plans, efficacy data, and pathology specimen information from multiple centers.
2. Use LC-MS/MS proteomics technology to screen for key protein markers related to T-DXd efficacy and use bioinformatics analysis to identify predictive protein indicators.
3. Extract IHC staining features from pathological images and evaluate their correlation with efficacy alongside clinical data.
4. Integrate proteomics, pathology, and clinical big data, using AI technologies such as foundational pathology models (like TITAN), biomedical large language models (like BioBERT), and protein large language models (like ESM2-15B). Apply a multiple instance learning strategy to build a multimodal efficacy prediction model, and evaluate the model's performance on the training set using 5-fold cross-validation.
5. Establish an internal validation cohort (200 cases) and a multicenter external validation cohort (300 cases). Considering that the external validation group may lack proteomics data, the multimodal model will be fine-tuned and distilled into a simplified predictive model based on standard IHC features (HER-2, ER, PR, Ki-67, plus key protein markers identified from proteomics) and clinical text information, then its performance will be verified in the external cohort.

Ultimately, this research will create an AI tool to support clinical decision-making, promoting personalized treatment for HER-2 positive and low-expression breast cancer and the clinical adoption of AI in healthcare.

Conditions

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • China

Study Locations

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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 NCT07689929 on ClinicalTrials.gov