Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-21 @ 8:30 AM
Study NCT ID:
NCT05795335
Status:
RECRUITING
Last Update Posted:
2023-05-16
First Post:
2023-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-14', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)', 'description': 'PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years', 'description': 'Overall survival is defined as the time from starting CDK4/6 inhibitor 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 2.5 years)', 'description': 'Adverse events during CDK4/6 regimen will be assessed according to the NCI CTCAE v5.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locoregionally Recurrent', 'Metastatic', 'CDK4/6 Inhibitors'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hormone receptor-positive breast cancer patients who have received or plan to receive CDK4/6 inhibitors for advanced disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 and older\n* Confirmed diagnosis of hormone receptor-positive breast cancer.\n* Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.\n* Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.\n* ECOG 0-2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Subjects disable to swallow pills.\n* History of immunodeficiency disease'}, 'identificationModule': {'nctId': 'NCT05795335', 'briefTitle': 'CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study', 'orgStudyIdInfo': {'id': 'KY2022-097-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients have received or plan to receive CDK4/6 inhibitors for advanced disease.', 'interventionNames': ['Drug: CDK4/6 inhibitor']}], 'interventions': [{'name': 'CDK4/6 inhibitor', 'type': 'DRUG', 'description': 'CDK4/6 inhibitors', 'armGroupLabels': ['Patients have received or plan to receive CDK4/6 inhibitors for advanced disease.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jinsong Lu, MD', 'role': 'CONTACT', 'email': 'lujingsong@renji.com'}], 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ziping Wu, MD', 'role': 'CONTACT', 'email': 'wuziping@renji.com', 'phone': '86(21)68385569'}, {'name': 'Qi Lu', 'role': 'CONTACT', 'email': 'rjllb3364@163.com', 'phone': '86(21)68383364'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Jinsong Lu, Chief of Breast Surgery Department, RenJi Hospital', 'investigatorFullName': 'Jinsong Lu', 'investigatorAffiliation': 'RenJi Hospital'}}}}