Predictive Value of Tumor Vascular Normalization Scoring in HER-2 Positive Breast Cancer

N/AActive Not RecruitingNCT06868758

Chongqing General Hospital50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HER2 Positive Breast Carcinoma Neoadjuvant Therapy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female breast cancer patients aged ≥18 years planned for neoadjuvant therapy. * Histopathologically confirmed HER2-positive status (IHC 3+ or IHC 2+ with positive FISH confirmation). * Mentally competent, no psychiatric disorders, with good compliance to treatment and follow-up. * Voluntarily participate and provide written informed consent. Exclusion Criteria: * HER2-negative breast cancer. * Pregnant, planning pregnancy, or lactating women. * History of allergic predisposition or known/suspected allergy to study drugs. * Participation in other clinical trials within the past 4 weeks or planned enrollment. * Other conditions deemed ineligible by the investigator.

Outcomes

Primary Outcomes

Correlation between VNS and Therapeutic Outcomes

Predictive value of VNI for pCR (ROC curve analysis). Unit of Measure: Statistical correlation coefficients (R²/AUC)

Time frame: Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).

Secondary Outcomes

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)