Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-03-06 @ 2:31 PM
Study NCT ID:
NCT02207335
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2014-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer
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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic 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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-21', 'studyFirstSubmitDate': '2014-04-22', 'studyFirstSubmitQcDate': '2014-07-30', 'lastUpdatePostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RECIST 1.1', 'timeFrame': '-7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39634173', 'type': 'DERIVED', 'citation': 'Liu X, Zhao W, Jia Y, Shi Y, Wang X, Li S, Zhang P, Wang C, Hao C, Tong Z. A non-inferiority, phase III trial of gemcitabine plus capecitabine versus gemcitabine plus carboplatin as first-line therapy and tumor-infiltrating lymphocytes as a prognostic biomarker in patients with advanced triple-negative breast cancer. Ther Adv Med Oncol. 2024 Dec 3;16:17588359241240304. doi: 10.1177/17588359241240304. eCollection 2024.'}, {'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': 'Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.', 'detailedDescription': 'A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or metastatic breast cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 18-70 years old\n* ECOG 0-1\n* Expected lifetime more than 12 weeks\n\nExclusion Criteria:\n\n* Pregnancy\n* Brain Metastasis,\n* Severe Infection'}, 'identificationModule': {'nctId': 'NCT02207335', 'briefTitle': 'Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'CIH-TZS-20140421-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine，Capecitabine', 'description': 'Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14', 'interventionNames': ['Drug: Gemcitabine，Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine, Carboplatin', 'description': 'Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8', 'interventionNames': ['Drug: Gemcitabine, Carboplatin']}], 'interventions': [{'name': 'Gemcitabine，Capecitabine', 'type': 'DRUG', 'description': 'Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14', 'armGroupLabels': ['Gemcitabine，Capecitabine']}, {'name': 'Gemcitabine, Carboplatin', 'type': 'DRUG', 'description': 'Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8', 'armGroupLabels': ['Gemcitabine, Carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300061', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongsheng Tong, Master', 'role': 'CONTACT', 'email': '18622221181@163.com', 'phone': '+86 18622221181'}], 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Zhongsheng Tong, Master', 'role': 'CONTACT', 'email': '18622221181@163.com', 'phone': '+86 18622221181'}], 'overallOfficials': [{'name': 'Zhongsheng Tong, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}