Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-01 @ 7:21 PM
Study NCT ID:
NCT03405168
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2018-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-14', 'studyFirstSubmitDate': '2018-01-14', 'studyFirstSubmitQcDate': '2018-01-14', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival (PFS)', 'timeFrame': '1years', 'description': 'the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause'}], 'secondaryOutcomes': [{'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'}, {'measure': 'clinical benefit rate (CBR)', 'timeFrame': '6 months', 'description': 'the proportion of patients with tumors complete response, partial response, and stable disease'}, {'measure': 'overal survival(OS)', 'timeFrame': '3 years', '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': {'conditions': ['Advanced Breast Cancer', 'Antibiotic', 'Stable Disease With a Trend of Progression']}, 'referencesModule': {'references': [{'pmid': '32390277', 'type': 'DERIVED', 'citation': "Wang X, Li J, Shi W, Huang Z, Xia W, Huang J, Su Y, Wang S, Shi Y, Bi X, Yuan Z. Efficacy of Moxifloxacin plus Treatment of Physician's Choice in Patients with Metastatic Breast Cancer. Oncologist. 2020 Oct;25(10):e1439-e1445. doi: 10.1634/theoncologist.2020-0364. Epub 2020 Jun 1."}]}, 'descriptionModule': {'briefSummary': 'This is a phase II,single center,prospective, single arm clinical trial. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced 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 quinolones antibiotics can increase anti-tumor effect. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female ≥ 18 years, ≤70 years.\n* Has measurable metastatic MBC, with at least 1 measurable lesion per RECIST criteria.\n* Fail first-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* Hypersensitivity to moxifloxacin or other quinolones.\n* Tendon damage,peripheral neuropathy,myasthenia gravis.\n* Rapidly progressive visceral disease not suitable for further therapy.\n* Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV\n* With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment\n* Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent\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': 'NCT03405168', 'briefTitle': 'Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'SYSUCC-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'routine therapy plus moxifloxacin', 'description': "Routine therapy (chemotherapy, endocrine therapy or target therapy) is according to physician's choice.", 'interventionNames': ['Drug: Moxifloxacin Hydrochloride 400mg Tablet']}], 'interventions': [{'name': 'Moxifloxacin Hydrochloride 400mg Tablet', 'type': 'DRUG', 'description': 'Moxifloxacin is oral administration, 400 mg once a day, D1 to D7, 28 days as one cycle.', 'armGroupLabels': ['routine therapy plus moxifloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongyu Yuan', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'jiajia huang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun-yatsen University Cancer center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Zhong-yu Yuan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}