Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-04 @ 4:12 PM
Study NCT ID:
NCT06868758
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Tumor Vascular Normalization Scoring in HER-2 Positive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples \\& FFPE tumor blocks'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '18 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-09', 'studyFirstSubmitDate': '2025-03-01', 'studyFirstSubmitQcDate': '2025-03-09', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}], 'secondaryOutcomes': [{'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).', 'description': "Ginsenoside Exposure Measurement:\n\nTool: 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\n\nVascular Normalization Measurement:\n\nTool: Dynamic Contrast-Enhanced MRI (DCE-MRI) with Extended Tofts Model Parameter: Vascular Normalization Index (VNI)\n\nComponents:\n\nK\\<sup\\>trans\\</sup\\> (unit: min\\<sup\\>-1\\</sup\\>) Plasma volume fraction (v\\<sub\\>p\\</sub\\>, unit: %) Calculation: Composite score (range 0-1) derived from principal component analysis\n\nStatistical Correlation:\n\nMethod: Spearman's rank correlation Unit: Spearman's ρ (range: -1 to 1)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tumor vascular normalization score', 'anti-HER2 antibody', 'Treatment efficacy'], 'conditions': ['HER2 Positive Breast Carcinoma', 'Neoadjuvant Therapy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female HER2 positive breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female breast cancer patients aged ≥18 years planned for neoadjuvant therapy.\n* Histopathologically confirmed HER2-positive status (IHC 3+ or IHC 2+ with positive FISH confirmation).\n* Mentally competent, no psychiatric disorders, with good compliance to treatment and follow-up.\n* Voluntarily participate and provide written informed consent.\n\nExclusion Criteria:\n\n* HER2-negative breast cancer.\n* Pregnant, planning pregnancy, or lactating women.\n* History of allergic predisposition or known/suspected allergy to study drugs.\n* Participation in other clinical trials within the past 4 weeks or planned enrollment.\n* Other conditions deemed ineligible by the investigator.'}, 'identificationModule': {'nctId': 'NCT06868758', 'briefTitle': 'Predictive Value of Tumor Vascular Normalization Scoring in HER-2 Positive Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing General Hospital'}, 'officialTitle': 'Predictive Value of Tumor Vascular Normalization Scoring in the Response to Neoadjuvant Therapy in HER-2 Positive Breast Cancer: an Observational Study', 'orgStudyIdInfo': {'id': 'JRIIT-08-01'}}, 'armsInterventionsModule': {'armGroups': [{'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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '401121', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Chongqing General Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}