Breast cancerwith HER2 positive and low expression
Conditions
Interventions
Internal Validation Team:None
External Verification Team:None
Predictive model test group:None
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Retrospective Cohort (Modeling and Validation): 1. Age =18 years, female; 2. Advanced breast cancer confirmed by histopathology (AJCC 8th edition Stage IV); 3. HER2 status clearly defined: Positive group: IHC 3 or IHC 2 with FISH amplification; 2.Low-expression group: IHC 1 or IHC 2 without FISH amplification; 4. Received at least 2 cycles of Enhertu monotherapy; 5. Complete baseline IHC slides (HER2, ER, PR, Ki-67) and HE-stained slides available; 6. Efficacy evaluation according to RECIST 1.1 and follow-up data available (PFS or ORR). Prospective Cohort (External Validation): 1. Meet criteria 1-3 above; 1. Planned to receive Enhertu monotherapy as second-line or later treatment; 2.if patients are HER2 positive, they should have received neoadjuvant/adjuvant H(P) therapy and experienced metastatic relapse within 12 months after treatment completion. Anti-HER2 treatment after relapse is considered second-line therapy; 3. Signed informed consent, agreeing to provide clinical information such as imaging and pathology data before and after treatment.
Exclusion criteria
Exclusion criteria: All cohorts: 1. Baseline IHC or HE slide quality not up to standard (e.g., faded, folded, tissue loss >10%); 2. Previously treated with other HER2-ADC drugs; 3. History of other malignant tumors (except non-melanoma skin cancer or more than 5 years without recurrence); 4. Currently participating in other interventional clinical trials (excluding completed past trials); 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 interpret (e.g., combined local radiotherapy, severe infections, etc.). Additional exclusions for the prospective cohort: 1. Pregnant or breastfeeding women; 2. Presence of contraindications for Enhertu (e.g., history of ILD, left ventricular ejection fraction <50%, etc.); 3. Unable to comply with regular follow-up (e.g., living in remote areas, mental disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance: AUC, accuracy, sensitivity, specificity, positive predictive value, negative predictive value; | — |
Countries
China
Contacts
Public ContactHaiHu
Zhejiang Cancer Hospital
Outcome results
None listed