Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Female patients diagnosed with invasive HRpositive, HER2-negative breast cancer. Histologically-confirmed invasive carcinoma of the breast, stage I to stage III Available archival H&E slide from diagnostic core biopsy or primary surgery. Must have the following recorded clinicopathologic variables, for eligibility and for applying the AI model: grade, age, ER, PR, HER2 at diagnosis. Recorded follow-up events and time to events, with a minimum of 5 years to last contact or or documented death before 5 years. Age at diagnosis more than 18 years To reduce bias, a consecutive patient data collection is important, where all eligible patients diagnosed within a fixed period of time will be included. i.e. all consecutively-diagnosed eligible patients diagnosed between 2014 to 2015, if required study will be extended to 2016.
Exclusion criteria
Exclusion criteria: Patients with distant metastases at diagnosis should be excluded. Patients with non-available or Poor quality pathology material will be excluded. Patients with no follow up update beyond 3 years will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the association of the AI-generated risk score (both as continuous and categorical variables) with 5-year patient outcomes. The primary endpoint is distant recurrence-free interval Protocol_Version__1.0 dated 22 Aug 2025 Page 4 of 7(DRFI). Secondary endpoints include recurrence-free interval (RFI), disease-free survival (DFS), and breast cancer-specific survivalTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To perform a utility analysis to estimate the proportion of patients whose chemotherapy treatment decisions might potentially change based on the AI-derived risk classification.Timepoint: 2 year | — |
Countries
India
Contacts
Public ContactYogesh Kembhavi
Tata Memorial Center
Outcome results
None listed