Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT06341894
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720752', 'term': 'dalpiciclib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1163}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2024-02-24', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'invasive Disease-free Survival (iDFS)', 'timeFrame': 'From enrollment until time of events up to 3 years', 'description': 'Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Disease-free Survival (DFS)', 'timeFrame': 'From enrollment until time of events up to 3 years', 'description': 'Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.'}, {'measure': 'AEs and SAEs', 'timeFrame': 'From the first administration to one months after the last drug administration，up to one month', 'description': 'Adverse events and Adverse events and serious adverse events according to CACTE 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is ≥ 18 years-old\n* Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)\n* Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)\n* Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0\n* Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion\n* From operation to enrollment should not exceed 12 months\n* Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n\nExclusion Criteria:\n\n* metastatic disease (Stage IV) or inflammatory breast cancer\n* Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.\n* Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);\n* A history of allergy to the drugs in this study；\n* Unable or unwilling to swallow tablets\n* History of gastrointestinal disease with diarrhea as the major symptom.'}, 'identificationModule': {'nctId': 'NCT06341894', 'briefTitle': 'Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer', 'orgStudyIdInfo': {'id': 'OBU-II-BC-126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Dalpiciclib and endocrine therapy', 'interventionNames': ['Drug: Dalpiciclib', 'Drug: Endocrine therapy']}], 'interventions': [{'name': 'Dalpiciclib', 'type': 'DRUG', 'otherNames': ['CDK4/6 inhibitor'], 'description': 'CDK4/6 inhibitor dalpiciclib, 100mg orally qd', 'armGroupLabels': ['Treatment']}, {'name': 'Endocrine therapy', 'type': 'DRUG', 'description': 'Fulvestrant/AI', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoan Liu, Professor', 'role': 'CONTACT', 'email': 'liuxiaoan@126.com', 'phone': '025-68308162'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Xiaoan Liu, Professor', 'role': 'CONTACT', 'email': 'liuxiaoan@126.com', 'phone': '025-68308162'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liu Xiaoan', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}