Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT06405269
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-14
First Post:
2024-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Regular blood tests are performed to monitor the patient's lipid profile"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2024-05-04', 'studyFirstSubmitQcDate': '2024-05-04', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who developed LDL-C abnormalities in 3 groups', 'timeFrame': '2 years', 'description': 'Observe and compare differences between groups'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who developed TC，LDL-C，and TG abnormalities in 3 groups', 'timeFrame': '2 years', 'description': 'Observe and compare differences between groups'}, {'measure': 'Proportion of patients developing fatty liver in 3 groups', 'timeFrame': '2 years', 'description': 'Observe and compare differences between groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Neoplasms', 'Lipid Profile']}, 'descriptionModule': {'briefSummary': 'Previous studies have shown differences in the effects of different endocrine drugs on blood lipids in breast cancer, and dyslipidaemia is a major risk factor for cardiovascular disease, and it has been previously reported that the leading cause of death in postmenopausal patients with breast cancer is cardiovascular disease, but the effects of endocrine drug therapy on blood lipids in young breast cancer patients (age ≤40) are not clear. Previously, our group conducted a preliminary retrospective analysis of young patients on endocrine therapy and found that dyslipidaemia was also a common adverse effect of treatment in young breast cancer patients; therefore, dyslipidaemia induced by antineoplastic therapy not only occurs in postmenopausal patients, but is also prevalent in premenopausal and even younger patients. Therefore, this study intends to evaluate the effects of different treatment regimens on lipids in early-stage young breast cancer patients and to explore the optimal timing of lipid-lowering drug interventions to provide a basis for clinical practice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young breast cancer patients who fulfil the following criteria: less than or equal to 40, surgically resectable, requiring (neo)adjuvant chemotherapy or endocrine therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECOG score 0-1\n* Resectable breast cancer\n* No distant metastases on postoperative imaging assessment\n* Patients proposed for (neo)adjuvant therapy\n* No previous oral lipid-lowering drugs, serum LDL-C level within normal range, i.e. LDL-C value: \\<3.4 mmol/L\n* No fatty liver by liver ultrasound/CT examination\n* No major organ dysfunction\n\nExclusion Criteria:\n\n* Patients with pre-existing hyperlipidaemia, coronary heart disease, fatty liver disease, or who have received or are receiving lipid-lowering medication\n* Enrolled in another study or less than or equal to 4 weeks since discontinuation of other medications\n* Presence of severe dysfunction of vital organs\n* Patients with other malignancies (except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumours that have been cured for at least 5 years)\n* Acute infectious diseases or chronic infectious diseases in active stage\n* History of uncontrolled epilepsy, central nervous system disease or mental disorder'}, 'identificationModule': {'nctId': 'NCT06405269', 'briefTitle': 'Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'A Multicentre Prospective Cohort Study: Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'NCC3872'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adjuvant chemotherapy group（Hormone receptor negative breast cancer）', 'description': 'Patients receiving adjuvant chemotherapy after surgery for hormone receptor-negative breast cancer'}, {'label': 'Adjuvant chemotherapy group（Hormone receptor positive breast cancer）', 'description': 'Patients receiving adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer'}, {'label': 'Without adjuvant chemotherapy group（Hormone receptor positive breast cancer）', 'description': 'Patients without adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'PENG YUAN', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}