Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT06135194
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib
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': 'C000614160', 'term': 'trastuzumab deruxtecan'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central neryous system Progression Free Survival，CNS-PFS', 'timeFrame': '3years', 'description': 'The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)for intracranial and extracranial lesions', 'timeFrame': '3years', 'description': 'Percentage of patients with CompleteResponse (CR) and partial response (PartialResponse (PR)'}, {'measure': 'Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions', 'timeFrame': '3years', 'description': 'Percentage of patients with complete response, partial response, and StableDisease (SD)≥6 months'}, {'measure': 'Overall survival (Oversall Survival, OS) and security', 'timeFrame': '5years', 'description': 'The interval between the start of treatment and death from any cause'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with brain metastases from HER2 positive breast cancer after treatment with pyrotinib', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records\n\nExclusion Criteria:\n\n* Has uncontrolled or significant cardiovascular disease\n* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening\n* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study'}, 'identificationModule': {'nctId': 'NCT06135194', 'briefTitle': 'Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib', 'organization': {'class': 'OTHER', 'fullName': 'Beijing 302 Hospital'}, 'officialTitle': 'Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment', 'orgStudyIdInfo': {'id': 'DS8021-Brain metastases'}}, 'armsInterventionsModule': {'interventions': [{'name': 'T-DXd', 'type': 'DRUG', 'otherNames': ['DS-8201'], 'description': 'Efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Wang', 'role': 'CONTACT', 'email': 'wangtaotg@163.com', 'phone': '01066947250'}], 'facility': 'The Fifth Medical Center of PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Wang', 'role': 'CONTACT', 'email': 'wangtao@163.com', 'phone': '01066947250'}], 'facility': 'The Fifth Medical Center of PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'jinmei zhou', 'role': 'CONTACT', 'email': 'jinzhu2714@sina.com', 'phone': '010-66947250'}, {'name': 'xuexue wu', 'role': 'CONTACT', 'email': '2858648736@qq.com', 'phone': '010-66947250'}], 'overallOfficials': [{'name': 'tao wang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing 302 Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}