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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Correlation between VNS and Therapeutic Outcomes — 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)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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