Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-29 @ 6:44 AM
Study NCT ID:
NCT00087620
Status:
TERMINATED
Last Update Posted:
2017-02-03
First Post:
2004-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic 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': 'D000069287', 'term': 'Capecitabine'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2004-07-12', 'studyFirstSubmitQcDate': '2004-07-13', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have provided written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice\n* Be female and at least 18 years of age. Note: must be 19 years of age if the patient is a resident of the state of Alabama\n* Be ambulatory (outpatient) and have a Karnofsky performance status of more than 70%\n* Have confirmed breast cancer with locally advanced and/or metastases\n* Have at least one site with defined tumor\n* Have met one of the study definitions of primary or nonprimary resistance to an anthracycline-containing therapy\n\nExclusion Criteria:\n\n* Pregnant/lactating women\n* Women of childbearing potential with either a positive or no pregnancy test\n* Women of childbearing potential unless using a reliable and appropriate contraceptive method (Postmenopausal women must have not had their period for at least 12 months to be considered of non-childbearing potential)\n* Prior treatment with chemotherapy in the advanced/metastatic setting\n* HER 2/neu positive status without prior treatment with trastuzumab\n* Prior treatment with IV bolus 5-FU, continuous 5-FU infusion, capecitabine or other oral fluoropyrimidines\n* Prior treatment with a taxane if less than 12 months passed from the time of therapy completion to relapse\n* Mitomycin C or nitrosoureas within 6 weeks preceding treatment start\n* Organ allografts requiring immunosuppressive therapy\n* Radiotherapy to the skeleton within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiotherapy\n* Hormonal therapy within 10 days preceding study treatment start\n* Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery\n* Blood transfusions/growth factors to aid hematologic recovery within 2 weeks prior to study treatment start\n* Participation in any investigational drug study within 4 weeks preceding treatment start\n* Prior unanticipated severe reaction to fluoropyrimidine therapy\n* Known hypersensitivity to 5-fluorouracil, taxanes or any of the components of capecitabine\n* Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues\n* Evidence of CNS metastases\n* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma\n* Clinically significant (i.e. active) cardiac disease\n* Abnormal laboratory values\n* Severe renal impairment\n* Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease\n* Lack of physical integrity of the upper GI tract\n* Life expectancy of less than 3 months\n* Unwilling/unable to comply with the protocol'}, 'identificationModule': {'nctId': 'NCT00087620', 'briefTitle': 'A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'ML17771'}}, 'armsInterventionsModule': {'interventions': [{'name': 'XELODA [capecitabine]', 'type': 'DRUG'}]}, 'contactsLocationsModule': 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