Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT01038804
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2009-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523798', 'term': 'sepantronium'}, {'id': 'D000077143', 'term': 'Docetaxel'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'dispFirstSubmitDate': '2013-07-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-12', 'studyFirstSubmitDate': '2009-12-22', 'dispFirstSubmitQcDate': '2013-07-11', 'studyFirstSubmitQcDate': '2009-12-22', 'dispFirstPostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'At the time of progression or death or at 2 year follow up'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (proportion of subjects with complete response or partial response)', 'timeFrame': 'At the time of progression or death or at 2 year follow up'}, {'measure': 'Overall survival', 'timeFrame': 'At the time of death or at 2 year follow up'}, {'measure': 'Duration of response', 'timeFrame': 'At the time of progression or at 2 year follow up'}, {'measure': 'Clinical benefit rate', 'timeFrame': 'At the time of progression or death or at 2 year follow up'}, {'measure': 'Time to response', 'timeFrame': 'At the time of response or at 2 year follow up'}, {'measure': 'Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)', 'timeFrame': 'Up to 30 days after last subject discontinues treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Metastatic', 'HER2 Negative', 'YM155'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.', 'detailedDescription': 'This is an outpatient study. All subjects enrolled in this study will receive a combined regimen of YM155 and docetaxel or docetaxel alone given during 21 day cycles. Each subject will be assessed at the end of each cycle to determine if the subject can continue to the next cycle. Each subject assigned to receive YM155 in combination with docetaxel will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.\n\nIf a subject discontinues treatment with at least stable disease (SD) that subject will complete follow-up visits every 12 weeks for 2 years or until initiating another systemic anti-breast cancer treatment, exhibiting progressive disease (PD), or death.\n\nEach subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible\n* No prior chemotherapy regimen for metastatic breast cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the Baseline Visit\n* The subject's life expectancy is estimated to be \\> 12 weeks at the Baseline Visit\n* The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period\n\nExclusion Criteria:\n\n* Hypersensitivity to docetaxel or polysorbate 80\n* Neuropathy ≥ Grade 2 at the Baseline Visit\n* Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination\n* The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody"}, 'identificationModule': {'nctId': 'NCT01038804', 'briefTitle': 'A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '155-CL-036'}, 'secondaryIdInfos': [{'id': '2009-012439-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A. YM155 plus docetaxel', 'interventionNames': ['Drug: YM155', 'Drug: Docetaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B. docetaxel alone', 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'YM155', 'type': 'DRUG', 'description': 'intravenous infusion', 'armGroupLabels': ['A. YM155 plus docetaxel']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'intravenous infusion', 'armGroupLabels': ['A. YM155 plus docetaxel', 'B. docetaxel alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kenmar Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94523', 'city': 'Pleasant Hill', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Cancer Research Group', 'geoPoint': {'lat': 37.94798, 'lon': -122.0608}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakeland Regional Cancer Center', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana Cancer Institute Foundation c/o Montana Cancer Specialists', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Oncology Specialists, PA', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet - Medical Oncology and Translational Research', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Grand Hopital de Charleroi - Site Notre Dame', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Sint-Augustinus GZA Ziekenhuizen', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'facility': 'FN Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '180 81', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Faculty Hospital Na Bulovce', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '86150', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Hämatologisch-onkologische Praxis', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Frauenklinik des Universitätsklinikums Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitatsklinikum Schleswig', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '54290', 'city': 'Trier', 'country': 'Germany', 'facility': 'Klinikum Mutterhaus der Borromaeerinnen', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': '4', 'city': 'Dublin', 'country': 'Ireland', 'facility': "St. Vincent's University Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '8', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'St. James Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '9', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Department of Medical Oncology', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centrum Onkologii-Instytut im.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '51-124', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Wojewodzki Szpital', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '454076', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '305035', 'city': 'Kursk', 'country': 'Russia', 'facility': 'State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD"', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '115478', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '357500', 'city': 'Pyatigorsk', 'country': 'Russia', 'facility': 'Pyatigorsk Oncology Dispensary', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'zip': '189646', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Scientific-Research Institute of Oncology named after Petrov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint-Petersburg State Medical University named after Pavlov', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443031', 'city': 'Samara', 'country': 'Russia', 'facility': 'State Healthcare Institution "Samara Regional Clinical Oncology Dispensary"', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '300053', 'city': 'Tula', 'country': 'Russia', 'facility': 'Tula Regional Dispensary', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Sr. Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}, {'name': 'United Kingdom Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Bournemouth Hospital'}, {'name': 'Poland Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centrum Onkologii-Instytut im.'}, {'name': 'Ireland Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's University Hospital, Ireland"}, {'name': 'Germany Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luisenkrankenhaus Duesseldorf'}, {'name': 'Czech Republic Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomayer Faculty Hosptial L.G.'}, {'name': 'Belgium Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Jules Bordet - Medical Oncology and Translational Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}