Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-01 @ 7:46 PM
Study NCT ID:
NCT06481956
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-01
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
T-DM1 Combined With CDK4/6 Inhibitor Ribociclib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589651', 'term': 'ribociclib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'up to 54 months', 'description': 'ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'up to 54 months', 'description': 'From date of first dose until the date of first documented progression or date of death from any cause, whichever came first.'}, {'measure': '2-year Overall Survival (OS)', 'timeFrame': 'up to 54 months', 'description': 'the overall survival rate in all patients from the date of first dose to the end of follow-up at 2 years.'}, {'measure': 'Objective Response Rate of Subgroup Population (ORR)', 'timeFrame': 'up to 54 months', 'description': 'Objective Response Rate of subgroup population (ER\\>=10% vs ER\\<10%)'}, {'measure': 'Adverse Event (AE)', 'timeFrame': 'up to 54 months', 'description': 'Evaluation performed using the National Cancer Institute (NCI)- Standard for Common Terminology for Adverse Events (CTCAE)v.5.0.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2-positive', 'Advanced breast cancer', 'Trastuzumab Emtansine', 'Ribociclib'], 'conditions': ['HER2-positive Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To explore the efficacy and safety of T-DM1 combined with CDK4/6 inhibitor Ribociclib in the treatment of HER2-positive advanced breast cancer.', 'detailedDescription': 'This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Trastuzumab Emtansine (T-DM1) combined with CDK4/6 inhibitor Ribociclib in the treatment of unresectable locally advanced or metastatic HER2-positive breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ā„18 at the time of signing the informed consent.\n* Patient's ability to follow the study protocol as determined by the investigator.\n* A representative tumor tissue sample is required to confirm a HER2-positive diagnosis.\n\nHER2 expression status and ER expression status of invasive cancer lesions were determined based on previous pathological sections or current pre-treatment biopsy materials, and the HER2 IHC assay was locally confirmed to be consistent with 3+, or IHC assay with 2+, and further FISH detection was positive before study enrollment.\n\n* At least one evaluable lesion was detected by CT or MRI (see protocol for additional details).\n* For metastatic or recurrent breast cancer, there is currently no opportunity for surgical radical resection.\n* Metastatic or recurrent breast cancer that has received at least first-line rescue therapy in the past must have been treated with trastuzumab and taxanes.\n* The Physical status (ECOG) score of the Eastern Tumor Collaboration group was 0 or 1.\n* Sufficient haematology and organ function to meet the definition of laboratory test results, which must be provided within 14 days before the start of study therapy.\n* Fertile women should remain abstinent (no heterosexual intercourse) or use contraceptive methods.\n\nExclusion Criteria:\n\n* Past treatment with other antibody-drug conjugate (ADC) drugs or anti-tumor therapy with CDK4/6 inhibitors.\n* Past treatment with other anti-HER2 drugs other than trastuzumab, pertuzumab and tyrosine kinase inhibitors (TKI).\n* Advanced breast cancer with central nervous system metastasis.\n* Patients who have developed other malignancies in the 5 years prior to screening, except adequately treated cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer.\n* Severe dysfunction of vital organs prior to enrollment (see protocol details).\n* Received an investigational drug within 28 days prior to initiation of study therapy.\n* Known hypersensitivity or hypersensitivity to CDK4/6 inhibitors.\n* The results of the serum pregnancy test were positive."}, 'identificationModule': {'nctId': 'NCT06481956', 'briefTitle': 'T-DM1 Combined With CDK4/6 Inhibitor Ribociclib', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Phase II Clinical Study of Trastuzumab Emtansine (T-DM1) Combined With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitor Ribociclib in the Treatment of Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Advanced Breast Cancer', 'orgStudyIdInfo': {'id': '[2023]-06-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T-DM1 combined with Ribociclib', 'description': 'Enrolled patients will receive (repeat every 21 days) :\n\nā T-DM1 3.6 mg/kg d1;ā Ribociclib 400 mg qd, d8-d21;\n\n\\* ER-positive patients will receive endocrine therapy at the same time: aromatase inhibitors or fulvestrant , and ovarian suppression or ovariectomy in premenopausal women.', 'interventionNames': ['Drug: Ribociclib Oral Tablet']}], 'interventions': [{'name': 'Ribociclib Oral Tablet', 'type': 'DRUG', 'description': 'Patients with advanced breast cancer with at least one evaluable lesion and histologically proven invasive breast cancer were eligible for inclusion. Histopathologically positive for HER2 (IHC 3+, or IHC 2+ with fluorescence in situ hybridization (FISH) positive, either primary or metastatic. Patients with advanced breast cancer must have previously received first-line therapy or initial rescue therapy and have been treated with trastuzumab against HER2.', 'armGroupLabels': ['T-DM1 combined with Ribociclib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yabing Zheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zheng Yabing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy director', 'investigatorFullName': 'Zheng Yabing', 'investigatorAffiliation': 'Zhejiang Cancer Hospital'}}}}