Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT07180056
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 229}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2033-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Invasive Disease-free Survival (iDFS)', 'timeFrame': 'From the date of surgery until time of event up to 2 years.', 'description': 'Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Disease-free Survival (DFS)', 'timeFrame': 'From the date of surgery until time of event up to 2 years', 'description': 'Disease-free survival time is defined as the time from date of surgery until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ (DCIS),or distant recurrence and death from any cause.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of surgery until time of event up to 2 years', 'description': 'Overall survival is defined as the time from surgery to death from any cause.'}, {'measure': 'Adverse events', 'timeFrame': 'From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 3 years)', 'description': 'Adverse events will be assessed according to the NCI CTCAE v5.0.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 and older\n* Patients with pathologically confirmed breast cancer without distant metastasis or local recurrence\n* HR+/HER2-\n* ECOG 0-3\n* Subjects meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors\n\nExclusion Criteria:\n\n* During pregnancy or lactation\n* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption'}, 'identificationModule': {'nctId': 'NCT07180056', 'briefTitle': 'Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Efficacy and Safety of Adjuvant CDK4/6 Inhibitors in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-negative Breast Cancer: a Real-world Study', 'orgStudyIdInfo': {'id': 'LY2025-108-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adjuvant CDK4/6 inhibitor', 'description': 'CDK4/6 inhibitors are drugs that block cell division in cancer cells. They are used with hormonal therapy for hormone receptor-positive breast cancer and may improve survival.', 'interventionNames': ['Drug: CDK4/6 inhibitor']}], 'interventions': [{'name': 'CDK4/6 inhibitor', 'type': 'DRUG', 'description': 'abemaciclib OR ribociclib', 'armGroupLabels': ['Adjuvant CDK4/6 inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenjin Yin', 'role': 'CONTACT', 'email': 'yinwenjin@renji.com', 'phone': '86(21)68385569'}], 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiaotong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wenjin Yin, M.D.', 'role': 'CONTACT', 'email': 'yinwenjin@renji.com', 'phone': '86(21)68385569'}], 'overallOfficials': [{'name': 'Wenjin Yin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renji Hospital,School of Medicine, Shanghai Jiaotong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenjin Yin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief of Breast Surgery Department', 'investigatorFullName': 'Wenjin Yin', 'investigatorAffiliation': 'RenJi Hospital'}}}}