Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00431067
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2007-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000077716', 'term': 'Afatinib'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study medication to 28 days after study drug discontinuation.', 'eventGroups': [{'id': 'EG000', 'title': 'Afatinib 50 mg', 'description': 'Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.', 'otherNumAtRisk': 41, 'otherNumAffected': 40, 'seriousNumAtRisk': 41, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Keratoconjunctivitis sicca', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 27}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'International normalised ratio decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukocytoclastic vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 50 mg', 'description': 'Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study medication to response measurement, up to 34 month', 'description': 'Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 50 mg', 'description': 'Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '117'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month', 'description': 'PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST criteria.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 50 mg', 'description': 'Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '427', 'comment': 'upper bound can not be calculated due to too few deaths.', 'groupId': 'OG000', 'lowerLimit': '397', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month', 'description': 'OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TS (14 patients died)'}, {'type': 'SECONDARY', 'title': 'Time to RECIST Tumour Reponse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 50 mg', 'description': 'Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median time of RECIST tumour response was not calculable as there were only 4 patients who responded.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose of study medication to time when OR measurement was taken.', 'description': 'The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'TS. There were only 4 patients who responded.'}, {'type': 'SECONDARY', 'title': 'Duration of Confirmed OR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Afatinib 50 mg', 'description': 'Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '153.3', 'spread': '162.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first OR to time of progression or death', 'description': 'Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS - patients with OR only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Afatinib 50 mg', 'description': 'Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '52 patients screened, 41 treated', 'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'On treatment at analysis cut-off date (22-Sep-2009)', 'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Other Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Non-compliance,lost to follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Afatinib 50 mg', 'description': 'Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '13.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2007-02-02', 'resultsFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2007-02-02', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-06', 'studyFirstPostDateStruct': {'date': '2007-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response (OR)', 'timeFrame': 'From first dose of study medication to response measurement, up to 34 month', 'description': 'Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month', 'description': 'PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST criteria.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month', 'description': 'OS was defined as the time from first treatment to death or to the last date the patient was known to be alive.'}, {'measure': 'Time to RECIST Tumour Reponse', 'timeFrame': 'From first dose of study medication to time when OR measurement was taken.', 'description': 'The time to OR was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST criteria.'}, {'measure': 'Duration of Confirmed OR', 'timeFrame': 'From first OR to time of progression or death', 'description': 'Duration of confirmed OR is measured from the time of first OR to the time of progression or death (or date of censoring for progression free survival).'}]}, 'conditionsModule': {'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nInclusion Criteria:\n\n1. Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+).\n2. Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.\n3. Age 18 years or older.\n4. Life expectancy of at least four (4) months.\n5. Written informed consent that is consistent with ICH-GCP guidelines.\n6. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2.\n7. Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should not have received treatment with hormone therapy within the last 2 weeks.\n8. Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade 1.\n9. Patients must have recovered from previous surgery.\n10. Patients must have measurable disease as defined by RECIST criteria.\n\nExclusion criteria:\n\nExclusion Criteria:\n\n1. Active infectious disease.\n2. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.\n3. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.\n4. Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal MRI scan at screening and be at least three months post-radiation or surgery.\n5. Cardiac left ventricular function with resting ejection fraction \\<50%.\n6. Absolute neutrophil count (ANC) less than 1500 cells/mm3.\n7. Platelet count less than 100 000 cells/mm3.\n8. Bilirubin greater than 1.5 mg/dl (\\>26 micromol /L, SI unit equivalent).\n9. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.\n10. Serum creatinine greater than 1.5 mg/dl (\\>132 micromol/L, SI unit equivalent).\n11. Women and men (and their partners) who are sexually active and unwilling to use a medically acceptable method of contraception.\n12. Pregnancy or breast-feeding.\n13. Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.\n14. Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).\n15. Patients unable to comply with the protocol.\n16. Active alcohol or drug abuse.\n17. Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.'}, 'identificationModule': {'nctId': 'NCT00431067', 'briefTitle': 'Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy', 'orgStudyIdInfo': {'id': '1200.11'}, 'secondaryIdInfos': [{'id': '2007-004805-80', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIBW 2992', 'description': 'BIBW 2992 (Afatinib) once daily until progression', 'interventionNames': ['Drug: BIBW 2992']}], 'interventions': [{'name': 'BIBW 2992', 'type': 'DRUG', 'otherNames': ['BIBW 2992 (Afatinib) once daily until progression'], 'armGroupLabels': ['BIBW 2992']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': '1200.11.3 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': '1200.11.7 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': '1200.11.4 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': '1200.11.2 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': '1200.11.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': '1200.11.5 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': '1200.11.4401 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'city': 'Crownhill, Plymouth', 'country': 'United Kingdom', 'facility': '1200.11.4402 Boehringer Ingelheim Investigational Site'}, {'city': 'Guildford', 'country': 'United Kingdom', 'facility': '1200.11.4406 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'city': 'London', 'country': 'United Kingdom', 'facility': '1200.11.4405 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Poole', 'country': 'United Kingdom', 'facility': '1200.11.4404 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'city': 'Truro', 'country': 'United Kingdom', 'facility': '1200.11.4403 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}