Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:23 PM
Study NCT ID:
NCT05300958
Status:
TERMINATED
Last Update Posted:
2025-07-22
First Post:
2022-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'D003676', 'term': 'Deferoxamine'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Difficulty accruing subjects the study accrual was closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-20', 'studyFirstSubmitDate': '2022-03-20', 'studyFirstSubmitQcDate': '2022-03-28', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '6 months', 'description': 'the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period'}], 'secondaryOutcomes': [{'measure': 'clinical benefit rate (CBR)', 'timeFrame': '6 months', 'description': 'the proportion of patients with tumors complete response, partial response, and stable disease'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': '6 months', 'description': 'the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause'}, {'measure': 'overal survival (OS)', 'timeFrame': '12 months', 'description': 'the time from the beginning of treatment for metastatic breast cancer to death from any cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deferoxamine plus chemotherapy', 'Objective Response Rate and safety'], 'conditions': ['Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression.', 'detailedDescription': 'This is a phase II, single center, prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that deferoxamine can increase anti-tumor effect. The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression after second-line. This study plans to recruit 30 subjects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has measurable metastatic triple-negative breast cancer, with at least 1 measurable lesion per RECIST criteria.\n* Fail second-line or above anti-tumor treatment\n* Evaluation is stable disease with a trend of progression.\n* Minimum life expectancy 16 weeks\n* Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis\n* ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks\n* Normal organ function.\n* Has signed a Patient Informed Consent Form.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) score of ≥ 2\n* Patients with severe liver and kidney insufficiency\n* Deferoxamine Ingredients allergy\n* With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment\n* Inability or unwillingness to comply with study procedures, including inability to take regular oral medication\n* Researchers consider it is not suitable for participation.'}, 'identificationModule': {'nctId': 'NCT05300958', 'briefTitle': 'Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer: A Single-armed, Phase II Trial', 'orgStudyIdInfo': {'id': 'SYSUCC-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Deferoxamine：50mg/kg+500ml normal saline (NS) plus chemotherapy', 'interventionNames': ['Drug: Deferoxamine Plus Chemotherapy']}], 'interventions': [{'name': 'Deferoxamine Plus Chemotherapy', 'type': 'DRUG', 'otherNames': ["Chemotherapy：Treatment of Physician's Choice (TPC)"], 'description': 'Deferoxamine：50mg/kg+500ml normal saline (NS)', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Zhong-yu Yuan, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhong-yu Yuan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}