Breast Cancer
Conditions
Interventions
Observation group:None
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Prospective study inclusion criteria: 1. Patients with stage II–III invasive breast cancer undergoing treatment at multiple centers, including West China Hospital of Sichuan University, between May 2026 and May 2027; 2. HR-positive (ER+, PR±), HER2-negative patients meeting CSCO guidelines for neoadjuvant indication and planned to receive neoadjuvant therapy, including standard neoadjuvant chemotherapy or other neoadjuvant regimens; 3. FFPE tissue samples obtained from core needle biopsy of the primary breast lesion prior to treatment, suitable for digital HE analysis (meeting requirements for tumor content and slide quality); 4. Patients who have not received any systemic anti-tumor treatment and have signed informed consent. Retrospective study criteria: 1. Multicenter diagnosed invasive breast cancer of stages II–III between 2012 and 2025; 2. HR-positive (ER+, PR +/-), HER2-negative, treated with neoadjuvant chemotherapy; 3. Pre-treatment core biopsy FFPE samples available for HE slide evaluation; 4. Complete postoperative pathology data available to determine pCR status; 5. Complete data on prognosis and survival outcomes
Exclusion criteria
Exclusion criteria: Prospective study section: 1. Patients with advanced breast cancer; 2. Samples that do not meet the analysis requirements or have no puncture samples; 3. Those who are opposed to the study. Retrospective study section: 1. Received new adjuvant therapy other than chemotherapy; 2. ER negative/PR positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response;Diagnostic performance: sensitivity (Sen), specificity (Spec), positive predictive value (PPV), negative predictive value (NPV); | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;disease free survival;overall survival; | — |
Countries
China
Contacts
Public ContactJing Jing,Zhang zhang
West China Hospital, Sichuan University
Outcome results
None listed