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

NCT06868758 | Active Not Recruiting

• 1 other identifier: JRIIT-08-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2 Positive Breast Carcinoma; Neoadjuvant Therapy

Keywords

Tumor vascular normalization score; anti-HER2 antibody; Treatment efficacy

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• Correlation between Ginsenoside Formulation Exposure and Tumor Vascular Normalization

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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female HER2 positive breast cancer patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing General Hospital: lead

Study Sites (1)

Chongqing General Hospital

Chongqing, Chongqing Municipality, 401121, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples \& FFPE tumor blocks

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 11, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

CN (1)