Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT00717951
Status:
UNKNOWN
Last Update Posted:
2008-07-25
First Post:
2008-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-24', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-17', 'lastUpdatePostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR,TTP,TTF and 2 year PFS', 'timeFrame': '2008-2010'}], 'secondaryOutcomes': [{'measure': 'safety and QOL', 'timeFrame': '2008-2010'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['advanced breast cancer', 'docetaxol', 'capecitabine', 'cisplatin'], 'conditions': ['Advanced Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34037241', 'type': 'DERIVED', 'citation': 'Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.'}, {'pmid': '33084020', 'type': 'DERIVED', 'citation': 'Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.'}]}, 'descriptionModule': {'briefSummary': 'Docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug for advanced breast cancer and potential effective drug for triple negative breast cancer.The study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine and docetaxol+cisplatin.\n\nThe second objective:Assess the safety and QOL.', 'detailedDescription': 'The study main inclusion criteria are:1.age≥18,KPS\\>70.2.anthracycline-pretreated patients with advanced breast cancer.3.at least 1 measurable lesion as defined by modified RECIST criteria.4.screening laboratory values within the following parameters:ANC ≥1.5×109/L,Hemoglobin≥10.0 g/dl，Platelet≥100×109/L. 5. signed ICF The patients will be randomised two group: docetaxol+capecitabine and docetaxol+cisplatin. According to AE, the dose will be adjusted.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age≥18y\n* KPS≥ 70\n* pathologic diagnosis of breast cancer\n* at least 1 measurable lesion as defined by modified RECIST criteria\n* screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/L platelet:≥100×109/L creatinine clearance rate: ≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal Alkaline phosphatase,Aspartate aminotransferase and Alanine aminotransferase:≤ 2.5×upper limits of normal（≤5×upper limits of normal if liver metastasis are present)\n* signed ICF\n* for women of child bearing potential,a negative serum or urine pregnancy test result before study entry.\n\nExclusion Criteria:\n\n* More than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.\n* prior exposure to 5-Fluorouracil continuous infusion.\n* prior exposure docetaxol for metastatic disease\n* Any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin'}, 'identificationModule': {'nctId': 'NCT00717951', 'briefTitle': 'A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Academy Military Medical Science, China'}, 'officialTitle': 'A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'TAX625'}, 'secondaryIdInfos': [{'id': 'CBCSG003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Arm A is "docetaxol+capecitabine" chemotherapy', 'interventionNames': ['Drug: docetaxol, cisplatin, capecitabine']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Arm B is "docetaxol+cisplatin" chemotherapy', 'interventionNames': ['Drug: docetaxol, cisplatin, capecitabine']}], 'interventions': [{'name': 'docetaxol, cisplatin, capecitabine', 'type': 'DRUG', 'description': 'docetaxol(75mg/m2 d1 every 21 days) combined with cisplatin(75mg/m2 d1 every 21 days) VS docetaxol( 75mg/m2 d1 every 21 days) combined with capecitabine(2000mg/m2 d1-14 every 21 days)', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'jiang zefei, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academy MMS,China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academy Military Medical Science, China', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Zefei Jiang, Binghe,Xu', 'oldOrganization': 'Academy Millitary Medical Science, China'}}}}