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

NCT ID: NCT06868758

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chongqing General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chongqing General Hospital

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

JRIIT-08-01

Identifier Type: -

Identifier Source: org_study_id