Ambispective study combining retrospective model development and prospective validation.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Retrospective Cohort (Modeling and Validation):
1. Female, 18 years or older;
2. Advanced breast cancer confirmed by pathology (AJCC 8th edition, stage IV);
3. HER2 status known;
4. Received at least 2 cycles of Pyrotinib monotherapy;
5. Complete baseline IHC slides (HER2, ER, PR, Ki-67) and HE-stained slides;
6. Efficacy assessed according to RECIST 1.1, with follow-up data (PFS or ORR).
Prospective Cohort (External Validation):
1. Meet criteria 1-3 above;
2. Planning to receive Pyrotinib monotherapy as second-line or later treatment; if HER2-positive, previously received neoadjuvant/adjuvant H(P) therapy, and had metastatic recurrence within 12 months after completing treatment, with post-recurrence anti-HER2 therapy considered second-line treatment.
3. Signed informed consent, agreeing to provide clinical info like imaging and pathology data before and after treatment.
You may not be if
All cohorts:
1. Baseline IHC or HE slides of poor quality (e.g., faded, folded, or tissue loss \>10%);
2. Previous treatment with other HER2-ADC drugs;
3. History of other malignancies (except non-melanoma skin cancer or cases with no recurrence for over 5 years);
4. Participation in other interventional clinical trials at the same time (past trials already completed are fine);
5. Lost to follow-up or missing key clinical data during treatment (e.g., efficacy evaluation, dose adjustment records);
6. Special treatment backgrounds that the AI model cannot analyze (e.g., combined local radiotherapy, severe infections, or other confounding factors).
Additional exclusions for the prospective cohort:
1. Pregnant or breastfeeding women;
2. Contraindications to Üher (e.g., history of ILD, left ventricular ejection fraction \<50%, etc.);
3. Unable to comply with regular follow-up (e.g., living in a remote area, mental disorders).
Clareo Health | Research on AI Models for Predicting Breast Cancer Treatment Effectiveness to Guide Her-2 Targeted ADC Therapy
