Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-04-09 @ 11:17 PM
Study NCT ID:
NCT01068704
Status:
COMPLETED
Last Update Posted:
2015-10-12
First Post:
2010-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Germany', 'Spain']}, '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': 'C552150', 'term': 'BMS-690514'}, {'id': 'D000077341', 'term': 'Lapatinib'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2012-03-24', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2010-02-12', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2010-02-12', 'dispFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months', 'timeFrame': 'Every 8 weeks according to CT scan'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival: defined as time to disease progression', 'timeFrame': 'Every 8 weeks'}, {'measure': "Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'", 'timeFrame': 'Every 8 weeks'}, {'measure': 'Frequency and severity of adverse events in all subjects', 'timeFrame': 'Every 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented invasive breast cancer\n* Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor\n* HER2+ and HER2- (Human Epidermal growth factor Receptor) disease\n* Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane\n* ECOG Performance status = 0 or 1\n\nExclusion Criteria:\n\n* Prior hormonal therapy for metastatic disease\n* Prior hormonal therapy with letrozole for adjuvant disease\n* Symptomatic brain metastases\n* Prior treatment with any tyrosine kinase inhibitor'}, 'identificationModule': {'nctId': 'NCT01068704', 'briefTitle': 'Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy', 'orgStudyIdInfo': {'id': 'CA187-016'}, 'secondaryIdInfos': [{'id': '2009-016622-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-690514 + Letrozole', 'interventionNames': ['Drug: BMS-690514', 'Drug: Letrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lapatinib + Letrozole', 'interventionNames': ['Drug: Lapatinib', 'Drug: Letrozole']}], 'interventions': [{'name': 'BMS-690514', 'type': 'DRUG', 'description': 'Tablets, Oral, 200 mg, once daily, \\~ 12 months depending on response', 'armGroupLabels': ['BMS-690514 + Letrozole']}, {'name': 'Lapatinib', 'type': 'DRUG', 'description': 'Tablets, Oral, 1500 mg, once daily, \\~ 12 months depending on response', 'armGroupLabels': ['Lapatinib + Letrozole']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Tablets, Oral, 2.5 mg, once daily, \\~ 12 months depending on response', 'armGroupLabels': ['BMS-690514 + Letrozole', 'Lapatinib + Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Abilene', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '77702', 'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Beaumont', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'zip': '76177', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Us Oncology Central Pharmacy', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'Yakima Valley Memorial Hospital/North Star Lodge', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}, {'zip': '5300', 'city': 'La Rioja', 'state': 'La Rioja Province', 'country': 'Argentina', 'facility': 'Local Institution', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': 'S2000DSK', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Local Institution', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '28030', 'city': 'Colima', 'state': 'Colima', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.24473, 'lon': -103.7127}}, {'zip': '34', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Local Institution', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}