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This study aims to evaluate the predictive value of the tumor vascular normalization score for the efficacy of neoadjuvant therapy in HER-2-positive breast cancer and explore its potential as a predictive biomarker. Through longitudinal observation of HER-2-positive breast cancer patients receiving standard treatment, we will analyze the correlation between vascular normalization scores and treatment responses (including objective response rate [ORR] and pathological complete response [pCR]) to optimize individualized therapeutic strategies. Additionally, an exploratory investigation will assess the impact of ginsenoside-containing formulations (e.g., Jinxing Capsule, Shenyi Capsule, Yiqi Jianpi Oral Liquid) on tumor vasculature and neoadjuvant therapy outcomes in HER-2-positive breast cancer, providing scientific insights for complementary therapeutic interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2 positive breast cancer | Female breast cancer patients with histopathologically confirmed HER2-positive status (defined as HER2 immunohistochemistry [IHC] 3+ or HER2 IHC 2+ with positive confirmation by fluorescence in situ hybridization [FISH]) who are planned to receive neoadjuvant therapy, including chemotherapy and HER2-targeted regimens. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between VNS and Therapeutic Outcomes | Predictive value of VNI for pCR (ROC curve analysis). Unit of Measure: Statistical correlation coefficients (R²/AUC) | Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between Ginsenoside Formulation Exposure and Tumor Vascular Normalization | Ginsenoside Exposure Measurement: Tool: Plasma concentration via Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry (UPLC-MS/MS) Parameter: Total ginsenoside plasma concentration (unit: ng/mL) Time Frame: Pre-dose and at Cycle 3 Day 1 (C3D1) of neoadjuvant therapy Vascular Normalization Measurement: Tool: Dynamic Contrast-Enhanced MRI (DCE-MRI) with Extended Tofts Model Parameter: Vascular Normalization Index (VNI) Components: K<sup>trans</sup> (unit: min<sup>-1</sup>) Plasma volume fraction (v<sub>p</sub>, unit: %) Calculation: Composite score (range 0-1) derived from principal component analysis Statistical Correlation: Method: Spearman's rank correlation Unit: Spearman's ρ (range: -1 to 1) |
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Inclusion Criteria:
Exclusion Criteria:
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Female HER2 positive breast cancer patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing General Hospital | Chongqing | Chongqing Municipality | 401121 | China |
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Blood samples & FFPE tumor blocks
| Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery). |