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

March 9, 2025 updated by: Chongqing General Hospital

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

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 Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 401121
        • Chongqing General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female HER2 positive breast cancer patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

Ktrans (unit: min-1) Plasma volume fraction (vp, 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)
Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 1, 2025

First Submitted That Met QC Criteria

March 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JRIIT-08-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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