Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-02-22 @ 12:46 AM
Study NCT ID:
NCT01891357
Status:
TERMINATED
Last Update Posted:
2019-09-17
First Post:
2013-05-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}], 'ancestors': [{'id': 'D044584', 'term': 'Carcinoma, Ductal'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000077341', 'term': 'Lapatinib'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], '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'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anja.braschoss@wsg-online.com', 'phone': '0049-176-82119153', 'title': 'Anja Braschoss, Consultant Clinical Research and Medical Writing', 'organization': 'on behalf of Westdeutsche Studiengruppe GmbH'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Only a limited number of core biopsies was available evaluation of dynamic biological changes.\n\nVery slow patient recruitment. Negative study results from ALTTO study did no longer justify further conduct.'}}, 'adverseEventsModule': {'timeFrame': 'AE collection from signature of ICF until end of study per patient, up to 3 years.', 'description': 'Safety population for analysis of toxicities, comprised of 61 patients who were allocated to intervention and received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Paclitaxel + Lapatinib + Trastuzumab', 'description': 'Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment\n\nBiopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology\n\npaclitaxel\n\nlapatinib\n\ntrastuzumab', 'otherNumAtRisk': 61, 'otherNumAffected': 59, 'seriousNumAtRisk': 61, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Blood and lymphatic system disorders', 'notes': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Ear and labyrinth disorders', 'notes': 'Ear and labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Eye disorders', 'notes': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Gastrointestinal disorders', 'notes': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 133, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'General disorders and administration site conditions', 'notes': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 53, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Hepatobiliary disorders', 'notes': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Immune system disorders', 'notes': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Infections and infestations', 'notes': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Injury, poisoning and procedural complications', 'notes': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Investigations', 'notes': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Metabolism and nMetabolism and nutrition disordersutrition disorders', 'notes': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Musculoskeletal and connective tissue disorders', 'notes': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Nervous system disorders', 'notes': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 66, 'numAffected': 59}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Psychiatric disorders', 'notes': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Renal and urinary disorders', 'notes': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Reproductive system and breast disorders', 'notes': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'notes': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Skin and subcutaneous tissue disorders', 'notes': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 93, 'numAffected': 59}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Vascular disorders', 'notes': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}], 'seriousEvents': [{'term': 'Death', 'notes': 'suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'anxiety', 'notes': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Cholecystitis', 'notes': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Decreased appetite', 'notes': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Dehydration', 'notes': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Device related thrombosis', 'notes': 'Device related thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'diarrhoea', 'notes': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Fatigue', 'notes': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'hypokaleamia', 'notes': 'hypokaleamia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'impaired healing', 'notes': 'impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Leukopenia', 'notes': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Mucosal Inflammation', 'notes': 'Mucosal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Ophthalmic herpes simplex', 'notes': 'Ophthalmic herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Pneumonia', 'notes': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'septic shock', 'notes': 'septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Subcutaneous abscess', 'notes': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Syncope', 'notes': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Urinary tract infection', 'notes': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}, {'term': 'Urosepsis', 'notes': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI-CTCAE version 4.'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathological Complete Response (pCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel + Lapatinib + Trastuzumab', 'description': 'Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment\n\nBiopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology\n\npaclitaxel\n\nlapatinib\n\ntrastuzumab'}], 'classes': [{'title': 'ypT0, ypN0', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'ypT0/is', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'ypT0/is, ypN0', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Average of 16 weeks', 'description': 'pCR was defined at the time of surgery and measured by size of residual tumor, proportion of vital cells within invasive carcinoma, number of positive lymph nodes (ypN) and size of the largest lymph node metastasis and ductal carcinoma in situ (ypT). pCR is defined as ypT0/is, ypN0. Further exploratory pCR definitions were ypT0, ypN0 (total pCR) and ypT0/is (near pCR).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Measurement of pCR: at time of surgery, measured by size of residual tumor, proportion of vital cells per invasive carcinoma, number of positive lymph nodes (ypN), size of largest lymph node metastasis, ductal carcinoma in situ (ypT). Definition of pCR: ypT0/is, ypN0. Exploratory pCR definition: ypT0, ypN0 (total pCR), ypT0/is (near pCR).'}, {'type': 'SECONDARY', 'title': 'Event Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel + Lapatinib + Trastuzumab', 'description': 'Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment\n\nBiopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology\n\npaclitaxel\n\nlapatinib\n\ntrastuzumab'}], 'timeFrame': '5-year survival', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and the outcome cannot be reported'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel + Lapatinib + Trastuzumab', 'description': 'Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment\n\nBiopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology\n\npaclitaxel\n\nlapatinib\n\ntrastuzumab'}], 'timeFrame': '5-year survival', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and the outcome cannot be reported'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proliferation and Apoptosis Genes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paclitaxel + Lapatinib + Trastuzumab', 'description': 'Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment\n\nBiopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology\n\npaclitaxel\n\nlapatinib\n\ntrastuzumab'}], 'timeFrame': 'One week before and after three weeks of treatment', 'description': 'Proliferation Ki-67, Aurora A Kinase (STK15), survivin, Myb-related protein B (MYBL2),Cyclin B1 and apoptosis genes Bcl2, Epidermal Growth Factor-like 2 (SCUBE2), cleaved caspase C3 will be assessed in the samples from diagnostic and sequential biopsy.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and the outcome cannot be reported'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paclitaxel + Lapatinib + Trastuzumab', 'description': 'Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment\n\nBiopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology\n\npaclitaxel\n\nlapatinib\n\ntrastuzumab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Patients should only have been registered for the study, if final results of screening evaluations were available and all inclusion/exclusion criteria met. This was not true for 3 patients.\n\nPatients should not have been registered due to distant metastasis. These patients were classified as screening failures and withdrawn from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Paclitaxel + Lapatinib + Trastuzumab', 'description': 'Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment\n\nBiopsy before and after three weeks of study treatment: Core biopsies for histological analyses, to be analysed by the central pathology\n\npaclitaxel\n\nlapatinib\n\ntrastuzumab'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50.3', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Demographics of All Registered Patients', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'ITT: Intent-to-treat population of all randomized patients without screening failures, comprising 61 patients (3 screening failures).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'Early termination due to significant lack of relevant patient data for evaluation of objectives.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2013-05-14', 'resultsFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-16', 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proliferation and Apoptosis Genes', 'timeFrame': 'One week before and after three weeks of treatment', 'description': 'Proliferation Ki-67, Aurora A Kinase (STK15), survivin, Myb-related protein B (MYBL2),Cyclin B1 and apoptosis genes Bcl2, Epidermal Growth Factor-like 2 (SCUBE2), cleaved caspase C3 will be assessed in the samples from diagnostic and sequential biopsy.'}], 'primaryOutcomes': [{'measure': 'Pathological Complete Response (pCR)', 'timeFrame': 'Average of 16 weeks', 'description': 'pCR was defined at the time of surgery and measured by size of residual tumor, proportion of vital cells within invasive carcinoma, number of positive lymph nodes (ypN) and size of the largest lymph node metastasis and ductal carcinoma in situ (ypT). pCR is defined as ypT0/is, ypN0. Further exploratory pCR definitions were ypT0, ypN0 (total pCR) and ypT0/is (near pCR).'}], 'secondaryOutcomes': [{'measure': 'Event Free Survival (EFS)', 'timeFrame': '5-year survival'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '5-year survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Unilateral primary invasive carcinoma of the breast'], 'conditions': ['Carcinoma, Ductal, Breast']}, 'descriptionModule': {'briefSummary': 'The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast cancer. The only treatment arm consists of Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks.', 'detailedDescription': 'Trastuzumab (T)-containing neoadjuvant chemotherapy has been reported to increase the probability of pathological complete response (pCR) in HER2 positive disease up to 67 %. Large trials revealed pCR rates (no remaining invasive and in situ components) of about 30-40 %, if anthracyclines/taxane based polychemotherapy was applied or about 40-45 % if no invasive tumor in the breast and lymph nodes was used as a pCR definition.\n\nNevertheless, resistance to trastuzumab remains one of the most important challenges in adjuvant and metastatic breast cancer therapy causing poor prognosis with an increased incidence of cerebral metastasis and limited therapeutic options after disease progression6. An improvement shows the combination of trastuzumab and lapatinib, which has been reported to have increased efficacy in in-vitro and in metastatic setting in patients who were mostly resistant to both therapies in the previous course of disease. Recent data from the neoadjuvant setting (neoALTTO) - on a paclitaxel backbone - showed a significantly higher pCR rate after L + T than with either compound separately (47 % vs. 20 % and 27.6 % respectively). Several trials are planned to evaluate the combination of both therapies in the adjuvant and neoadjuvant setting.\n\nClinical response measured by sequential evaluation of different proliferation markers (such as Ki-67) following a course of neoadjuvant chemotherapy has been demonstrated to correlate significantly with an increased risk of relapse in patients not achieving pathological complete response. It is therefore clinically relevant to evaluate such proliferation tools for early prediction of combination therapy efficacy (chemotherapy and HER2 targeted therapy). So far, it remains unclear which method of proliferation measurement is the optimal marker for response evaluation regarding a combined chemo-immunotherapy. However, measurement of proliferation and apoptosis genes as well as assessment of changes in Phosphatidylinositol 3-kinases (PI3K), Protein Kinase B (AKT), Insulin-like Growth Factor (IGF) and stem cell signalling after a short course of therapy could provide a unique signature for a dynamic response evaluation.\n\nThe planned trial will validate predictive markers and a dynamic model based on the sequential evaluation of different proliferation and apoptosis markers. Furthermore it will assess the pCR-rate after 12 weeks of therapy. The aim of the study is to define a predictive marker for the response evaluation of a combined chemo-immunotherapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female patients, age at diagnosis 18 - 75 years\n2. Histological confirmed unilateral primary invasive carcinoma of the breast\n3. Clinical Stage Tumor 1 (cT1) (\\> 1 cm) - Clinical Stage Tumor 4 (cT4) (if operable, inflammatory breast cancer is excluded)\n4. HER2 over-expressing tumor confirmed by: 3+ by Immuno-histochemistry (IHC) and/or HER2/neu gene amplification by fluorescence, chromogenic or silver in-situ hybridization \\[Fluorescent In-Situ Hybridization (FISH), Chromogenic In-Situ Hybridization (CISH) or Silver In-Situ Hybridization (SISH); \\> 6 HER2 gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥ 2.0\\]\n5. Clinically node positive disease or node negative disease\n6. No clinical evidence for distant metastasis (cM0) after conventional staging\n7. Performance Status Eastern Cooperative Oncology Group (ECOG) ≤ 1 or Karnofsky Index (KI) ≥ 80%\n8. Baseline Left Ventricular Ejection Fraction (LVEF) \\> 50% measured by echocardiography\n9. Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients\n10. The patient must be accessible for treatment and follow-up\n11. Written informed consent including a written informed consent for shipping of tumor block for central pathology review and evaluation prior to the start of any study procedures\n\nExclusion Criteria:\n\n1. Known hypersensitivity reaction to the compounds or incorporated substances\n2. Known polyneuropathy grade ≥ 2\n3. Have acute or currently active or requiring anti-viral therapy hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment).\n4. Prior malignancy with a disease-free survival of \\< 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri\n5. Prior or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor\n6. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry\n7. Male breast cancer\n8. Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment\n9. Breast feeding women\n10. Sequential breast cancer\n11. Lack of patient compliance\n12. Inadequate organ function including:\n\n * Leucocytes \\< 3.5 x 109/l\n * Platelets \\< 100 x 109/l\n * Absolute Neutrophil Count (ANC) \\< 1.5 x 109/l\n * Hemoglobin \\< 9 g/dl\n * Serum Creatinine \\> 1.5 mg/dl\n * Serum Bilirubin \\> 1.1 mg/dl\n * Alkaline phosphatase \\> 2.5 x Upper Limit of Normal (ULN)\n * Aspartate Transaminase (ASAT) and/or Alanine Transaminase (ALAT) \\> 2.5 ULN\n * Albumin \\< 2.5 g/dl\n13. Uncompensated cardiac function\n14. Malabsorption syndrome, disease significantly affecting gastrointestinal function\n15. Concomitant use of Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers"}, 'identificationModule': {'nctId': 'NCT01891357', 'briefTitle': 'Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'West German Study Group'}, 'officialTitle': 'A Multicenter Site, Open Label, Phase II Trial to Validate Predictive Markers for the Response Evaluation of a Combined Chemo-immunotherapy in Patients With HER2-positive Early Breast Cancer', 'orgStudyIdInfo': {'id': 'WSG-AM07 (Neo-PREDICT-HER2)'}, 'secondaryIdInfos': [{'id': '2012-003679-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel + Lapatinib + Trastuzumab', 'description': 'Paclitaxel 80 mg/m2 weekly for 12 weeks with lapatinib 750 mg P.O. daily and trastuzumab 2 mg/kg IV (loading dose 4 mg/kg) weekly for 12 weeks, biopsy before and after three weeks of study treatment', 'interventionNames': ['Procedure: Biopsy before and after three weeks of study treatment', 'Drug: paclitaxel', 'Drug: lapatinib', 'Drug: trastuzumab']}], 'interventions': [{'name': 'Biopsy before and after three weeks of study treatment', 'type': 'PROCEDURE', 'description': 'Core biopsies for histological analyses, to be analysed by the central pathology', 'armGroupLabels': ['Paclitaxel + Lapatinib + Trastuzumab']}, {'name': 'paclitaxel', 'type': 'DRUG', 'armGroupLabels': ['Paclitaxel + Lapatinib + Trastuzumab']}, {'name': 'lapatinib', 'type': 'DRUG', 'armGroupLabels': ['Paclitaxel + Lapatinib + Trastuzumab']}, {'name': 'trastuzumab', 'type': 'DRUG', 'armGroupLabels': ['Paclitaxel + Lapatinib + Trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73730', 'city': 'Esslingen am Neckar', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Klinikum Esslingen', 'geoPoint': {'lat': 48.73961, 'lon': 9.30473}}, {'zip': '74078', 'city': 'Heilbronn', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'SLK Kliniken', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'zip': '65929', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Klinikum Frankfurt Höchst', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '49124', 'city': 'Georgsmarienhütte', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Niels-Stensen-Kliniken', 'geoPoint': {'lat': 52.20296, 'lon': 8.0448}}, {'zip': '51067', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Krankenhaus Köln Holweide, Brustzentrum', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '44309', 'city': 'Dortmund', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Klinikum Westfalen GmbH - Knappschaftskrankenhaus', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '47053', 'city': 'Duisburg', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Bethesda Krankenhaus, Senologie', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '59073', 'city': 'Hamm', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'St. Barbara-KIinik', 'geoPoint': {'lat': 51.68033, 'lon': 7.82089}}, {'zip': '09116', 'city': 'Chemnitz', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Klinikum Chemnitz gGmbH', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '10713', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis für gynäkologische Onkologie am Brustzentrum City', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Mathias Warm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Krankenhaus Köln Holweide'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West German Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}