Clinical trial · Observational
Predictive Value of Tumor Vascular Normalization Scoring in HER-2 Positive Breast Cancer
Predictive Value of Tumor Vascular Normalization Scoring in the Response to Neoadjuvant Therapy in HER-2 Positive Breast Cancer: an Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Positive Breast Carcinoma | HER2-Positive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- HER2 positive breast cancer
- description
- 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.
Primary outcomes (1)
- measure
- Correlation between VNS and Therapeutic Outcomes
- timeFrame
- Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).
- description
- Predictive value of VNI for pCR (ROC curve analysis). Unit of Measure: Statistical correlation coefficients (R²/AUC)
Secondary outcomes (1)
- measure
- Correlation between Ginsenoside Formulation Exposure and Tumor Vascular Normalization
- timeFrame
- Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available