Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-14 @ 9:00 PM
Study NCT ID:
NCT02947061
Status:
UNKNOWN
Last Update Posted:
2016-10-31
First Post:
2016-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'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': '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': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '1 year'}, {'measure': 'objective response rate', 'timeFrame': '2 years'}, {'measure': 'Disease control rate', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Breast Cancer,first treatment, S1, Capecitabine'], 'conditions': ['Breast Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With Advanced Breast Cancer first-line treatment', 'detailedDescription': 'To compare progression free survival (PFS) of the S-1 combined with docetaxel followed by maintenance treatment with S-1 and capecitabine combined with docetaxel followed by maintenance therapy with capecitabine in patients with advanced breast cancer first-line treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 ≤ age ≤ 75;\n* ECOG 0-2, The expected survival time more than 3 months;\n* Histologically or cytologically proven locally advanced or advanced HER-2 negative breast cancer;\n* No chemical treatment after Cancer recurrence;\n* At least one measurable disease ( as per RECIST1.1);\n* Adequate bone marrow functions (ANC ≥1.5×109 /L, PLT ≥100×109 /L, HB ≥90 g/L);\n* Adequate renal functions(serum creatinine ≤ 1.5 ULN; creatinine clearance≥50 ml/min);\n* liver functions (serum bilirubin ≤ 1.5ULN, AST/ALT ≤ 2.5 ULN);\n* Written informed consent;\n* Pregnancy test (serum or urine) within 7 days of entry and willing to use the appropriate method of contraception.\n\nExclusion Criteria:\n\n* Previously chemotherapy with cytotoxic drugs\n* Pregnant, lactating women Did not take effective contraceptive measures\n* Adjuvant chemotherapy/ neoadjuvant chemotherapy with 5-FU-based chemotherapy or Paclitaxel -based chemotherapy within 1 year after recurrence;\n* Her-2 positive or unknown\n* Other trails Before 4weeks\n* Affection of the absorption of drugs(Unable to swallow、after gastrectomy、Chronic diarrhea and intestinal obstruction\n* Organs with rapid progression of invasion(Liver and lung lesions more than 1/2 organ area or hepatic insufficiency)\n* Central nervous system disorders or mental disorders\n* For docetaxel or fluorouracil or Twain 80 had serious adverse reactions or Allergy to 5-FU\n* Severe upper gastrointestinal ulcer or absorption dysfunction syndrome\n* Abnormal blood routine (ANC \\<1.5×109 /L, PLT \\<100×109 /L, HB \\<90 g/L);\n* Renal functions(serum creatinine \\> 1.5 ULN);\n* Liver functions (serum bilirubin \\> 1.5ULN\n* Brain metastases out of control\n* Other unapplicable'}, 'identificationModule': {'nctId': 'NCT02947061', 'briefTitle': 'S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer: a Phase 2, Prospective,Multicenter, Randomised Study', 'orgStudyIdInfo': {'id': 'CH-BC-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test group', 'description': 'S1 plus Docetaxel ：S-1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1', 'interventionNames': ['Drug: S1 plus Docetaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Capecitabine plus Docetaxel ：Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1', 'interventionNames': ['Drug: Capecitabine plus Docetaxel']}], 'interventions': [{'name': 'S1 plus Docetaxel', 'type': 'DRUG', 'description': 'S1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1', 'armGroupLabels': ['test group']}, {'name': 'Capecitabine plus Docetaxel', 'type': 'DRUG', 'description': 'Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Binghe Xu, M.D.', 'role': 'CONTACT', 'email': 'xubinghe@medmail.com.cn', 'phone': '86-10-88788826'}, {'name': 'Jiayu Wang, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'No.17 panjiayuannanli, Chaoyang District', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Binghe Xu, M.D.', 'role': 'CONTACT', 'phone': '010-87778826'}, {'name': 'Jiayu Wang, M.D.', 'role': 'CONTACT', 'phone': '010-87778826'}], 'overallOfficials': [{'name': 'Binghe Xu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences'}, {'name': 'Guohui Han, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tumor Hospital of Shanxi Province'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director, Department of Medical Oncology', 'investigatorFullName': 'Binghe Xu', 'investigatorAffiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}}}}