Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-27 @ 4:29 AM
Study NCT ID:
NCT01589159
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2012-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes
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': 'D005047', 'term': 'Etoposide'}], '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'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2012-04-28', 'studyFirstSubmitQcDate': '2012-04-30', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical benefit rate', 'timeFrame': '24 weeks after the treatment', 'description': 'Clinical benefit is defined as CR, PR, SD≥24 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a single-center, open-lable, non-comparative, prospective, phase Ⅱ efficacy and safety study. Eligible patients are enrolled in a single group. The investigators propose to determine the efficacy and safety of low-dose metronomic chemotherapy with Etoposide/Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and/or Taxanes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients between 18 and 65 years old\n* patients with metastatic breast cancer previousely treated with A/T\n* able and willing to give consent to participate in the study\n\nExclusion Criteria:\n\n* pregnant or lactating females\n* other tumor history\n* instable complication (e.g., myocardial infarction within 6 months,arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection\n* concurrent disease or condition that would make the patient inappropriate for study participation\n* resist to participate in the study'}, 'identificationModule': {'nctId': 'NCT01589159', 'briefTitle': 'A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'A Phase Ⅱ Study of an All-Oral Combination of Low-dose Etoposide/Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines and/or Taxanes', 'orgStudyIdInfo': {'id': 'BCP09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Drug: Capecitabine', 'Drug: Etoposide']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Drug:capecitabine 700mg/m2, twice daily on days 1-14.', 'armGroupLabels': ['Experimental']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Etoposide 30mg/m2, once daily on days 1-7.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Cancer Hospital & Institute', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yan Wei, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tao OUYANG', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chairman of Breast Center', 'investigatorFullName': 'Tao OUYANG', 'investigatorAffiliation': 'Peking University'}}}}