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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Jul 8, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Jun 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

900 participants (estimated)

Arms

• Arm: HER2-positive T-DXd-sensitive cohort
• Arm: HER2-positive T-DXd-resistant cohort
• Arm: HER2-low T-DXd-sensitive cohort
• Arm: HER2-low T-DXd-resistant cohort

Primary Outcome Measure

Area Under the Receiver Operating Characteristic Curve (AUC) of the Predictive Model [ Time Frame: Baseline (at initial diagnosis) ]

Central Contacts

• Hai Hu
  13556111018
  [email protected]

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