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NCT Number: NCT06868758

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

HER2 Positive Breast Carcinoma Neoadjuvant Therapy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chongqing General Hospital

Chongqing, Chongqing Municipality, 401121, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation between VNS and Therapeutic Outcomes

    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).

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

Secondary outcomes

  1. Correlation between Ginsenoside Formulation Exposure and Tumor Vascular Normalization

    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).

    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)

Sponsors and collaborators

Lead sponsor

Chongqing General Hospital

Other

Registry information

Official study title

Predictive Value of Tumor Vascular Normalization Scoring in the Response to Neoadjuvant Therapy in HER-2 Positive Breast Cancer: an Observational Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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