Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-01 @ 12:22 PM
Study NCT ID:
NCT01655992
Status:
TERMINATED
Last Update Posted:
2018-01-23
First Post:
2012-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)
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': 'D000069287', 'term': 'Capecitabine'}, {'id': 'C489337', 'term': 'potassium oxonate'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 386}}, 'statusModule': {'whyStopped': 'The sponsor decided to stop the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-21', 'studyFirstSubmitDate': '2012-07-27', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'response rate', 'timeFrame': '1.5 months'}, {'measure': 'overall survival', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['capecitabine', 'Tegafur，Gimeracil and Oteracil Potassium Capsules'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Comparing S1 generic With Capecitabine in Patients With Metastatic Breast Cancer.', 'detailedDescription': 'Comparing S1 generic(Tegafur，Gimeracil and Oteracil Potassium Capsules) With Capecitabine in Patients With Metastatic Breast Cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed breast cancer\n* Pretreated metastatic breast cancer not more than 2 lines chemotherapy\n* Have not been previously treated with capecitabine,oral fluracil\n* ECOG performance status of ≤ 1\n* Be female and ≥ 18 and ≤ 75 years of age\n* Have at least one target lesion according to the RECIST criteria 1.1\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* ECOG ≥ 2\n* Have been treated with capecitabine\n* Evidence of CNS metastasis\n* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer\n* Abnormal laboratory values: hemoglobin \\< 10.0 g/dl, absolute neutrophil count \\< 1.5×10\\^9/L, platelet count \\< 100×10\\^9/L, serum creatinine \\> upper limit of normal (ULN), serum bilirubin \\> ULN, ALT and AST \\> 5×ULN, AKP \\> 5×ULN\n* Serious uncontrolled intercurrent infection\n* Life expectancy of less than 3 months'}, 'identificationModule': {'nctId': 'NCT01655992', 'briefTitle': 'A Trial Comparing S1 Generic With Capecitabine in Metastatic Breast Cancer (MBC)', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Randomized Open Label Multicenter Phase 3 Trial Comparing S1 Generic With Capecitabine in Patients With Metastatic Breast Cancer.', 'orgStudyIdInfo': {'id': 'Fudan BR2012-09 CBCSG011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S1 generic', 'description': '40mg／m2 bid four weeks on two weeks off', 'interventionNames': ['Drug: S1 generic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'capecitabine', 'description': '2500mg／m2／day divided into twice two weeks on one week off', 'interventionNames': ['Drug: capecitabine']}], 'interventions': [{'name': 'capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': '2500mg／m2／day divided into twice two weeks on one week off', 'armGroupLabels': ['capecitabine']}, {'name': 'S1 generic', 'type': 'DRUG', 'otherNames': ['Tegafur，Gimeracil and Oteracil Potassium Capsules'], 'description': '40mg／m2 bid four weeks on two weeks off', 'armGroupLabels': ['S1 generic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xi-chun Hu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan Univeristy Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Director of department of medical oncology', 'investigatorFullName': 'Xichun Hu', 'investigatorAffiliation': 'Fudan University'}}}}