Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT03556358
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2018-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Poland'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}}}}, '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': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'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'}, {'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': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.lai@tanvex.com', 'phone': '19494838507', 'title': 'Study Director', 'organization': 'Tanvex'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events were recorded from Screening, while Adverse Events were recorded from Day 1 (Week 0) of Cycle 1 of study treatment through End of Treatment (Week 24).', 'description': 'Because study drug (TX05/trastuzumab) was not introduced until Cycle 5 of treatment, the analyses of AEs was focused on Cycles 5 through 8 of treatment. The following results include events that occurred on or after initiation of TX05 or Herceptin treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'TX05 (Trastuzumab)', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nTX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)', 'otherNumAtRisk': 394, 'deathsNumAtRisk': 394, 'otherNumAffected': 246, 'seriousNumAtRisk': 394, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Herceptin®', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nHerceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)', 'otherNumAtRisk': 400, 'deathsNumAtRisk': 400, 'otherNumAffected': 250, 'seriousNumAtRisk': 400, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral Sensory Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neuropathy Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diabetic Metabolic Decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vaginal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastrointestinal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Multiple Organ Dysfunction Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anaphylactic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Post Procedural Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ischemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fetal Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'COVID-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ejection Fraction Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 394, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 400, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '338', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TX05 (Trastuzumab)', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nTX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)'}, {'id': 'OG001', 'title': 'Herceptin®', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nHerceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)'}], 'classes': [{'title': 'Subjects who do not Meet pCR Criteria', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}]}, {'title': 'Subjects Meeting pCR Criteria', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0783', 'ciLowerLimit': '0.9185', 'ciUpperLimit': '1.2659', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Two one-sided hypothesis tests were performed for pCR in order to show that TX05 is equivalent to Herceptin:\n\n* TEST 1: H0a: θ1 / θ2 \\> 1.325 vs. H1a: θ1 / θ2 \\< 1.325\n* TEST 2: H0b: θ1 / θ2 \\< 0.755 vs. H1b: θ1 / θ2 \\> 0.755\n\nWhere θ1 is the proportion of pCR for subjects randomized to TX05 group, θ2 is the proportion of pCR for subjects randomized to Herceptin. Equivalence was concluded if the 95% CI of the risk ratio is completely contained within the pre-defined interval \\[0.755, 1.325\\].'}], 'paramType': 'NUMBER', 'timeFrame': '3-7 weeks following last dose of study treatment', 'description': 'Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population \\[includes all subjects who received at least one dose of study drug (TX05 or Herceptin) and had no major protocol deviations that impact the efficacy endpoints\\].'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TX05 (Trastuzumab)', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nTX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)'}, {'id': 'OG001', 'title': 'Herceptin®', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nHerceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)'}], 'classes': [{'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of Treatment (Week 24) or Early Termination Visit', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (ORR) = CR + PR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed on the modified intent-to-treat population. The modified intent-to-treat (mITT) population includes all subjects who were randomized and received at least 1 dose of TX05 or Herceptin.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TX05 (Trastuzumab)', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nTX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)'}, {'id': 'FG001', 'title': 'Herceptin®', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nHerceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '404'}, {'groupId': 'FG001', 'numSubjects': '405'}]}, {'type': 'Subjects Treated', 'comment': 'Treated: Subjects treated with epirubicin and /or cyclophosphamide in cycle 1.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '405'}]}, {'type': 'Subjects Receiving TX05 or Herceptin', 'comment': 'TX05 or Herceptin was received at Cycle 5', 'achievements': [{'groupId': 'FG000', 'numSubjects': '394'}, {'groupId': 'FG001', 'numSubjects': '400'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '393'}, {'groupId': 'FG001', 'numSubjects': '393'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Subjects Randomized that did not Treat', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subjects who Randomized and Treated but Drop prior to Cycle 5', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Discontinued Treatment after Cycle 5 due to Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Discontinued Treatment after Cycle 5 due to Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Discontinued Treatment after Cycle 5 due to Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Discontinued Treatment after Cycle 5 due to COVID-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Discontinued Treatment after Cycle 5 due to Other (Subject Decision)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 809 subjects were randomized to the study. Of these, 806 subjects initiated protocol treatment.', 'preAssignmentDetails': 'Of the 806 subjects who initiated protocol treatment, 794 subjects initiated Cycle 5 (when trastuzumab was added); of these 394 subjects received TX05 and 400 subjects received Herceptin.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'BG000'}, {'value': '400', 'groupId': 'BG001'}, {'value': '794', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TX05 (Trastuzumab)', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nTX05 (trastuzumab): 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)'}, {'id': 'BG001', 'title': 'Herceptin®', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles\n\nHerceptin®: 8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)\n\nPaclitaxel: 175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)\n\nEpirubicin: 75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)\n\nCyclophosphamide: 600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '11.80', 'groupId': 'BG000'}, {'value': '53.4', 'spread': '10.83', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '11.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '394', 'groupId': 'BG000'}, {'value': '400', 'groupId': 'BG001'}, {'value': '794', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '653', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '286', 'groupId': 'BG001'}, {'value': '578', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hormone Receptor Status', 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '507', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG', 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '316', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '621', 'groupId': 'BG002'}]}, {'title': 'Grade 1', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Grade 0: Fully active, able to carry on all pre-disease activities without restriction\n\nGrade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.\n\nGrade 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.\n\nGrade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.\n\nGrade 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.\n\nGrade 5: Dead', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Stage', 'classes': [{'categories': [{'title': 'IIA', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}, {'title': 'IIB', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}, {'title': 'IIIA', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "* Enrolled subjects should have Stage II/IIIa breast cancer.\n* Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor size, lymph node involvement, metastasis to distant sites) staging system.\n* A low grade number (grade 1) usually means the cancer is slower-growing and less likely to spread. A high grade number (grade 3) means a faster-growing cancer that's more likely to spread. An intermediate grade number (grade 2) means the cancer is growing faster than a grade 1 cancer but slower than a grade 3 cancer.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population/The modified intent-to-treat (mITT) population includes all subjects who are randomized into the study and receive at least 1 dose of TX05 or Herceptin.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-30', 'size': 924553, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-28T15:19', 'hasProtocol': True}, {'date': '2021-02-04', 'size': 2863526, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-28T15:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 809}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-07', 'studyFirstSubmitDate': '2018-06-01', 'resultsFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-07', 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)', 'timeFrame': '3-7 weeks following last dose of study treatment', 'description': 'Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0).'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'End of Treatment (Week 24) or Early Termination Visit', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (ORR) = CR + PR.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trastuzumab', 'Herceptin'], 'conditions': ['Breast Cancer', 'Breast Neoplasms', 'HER2-positive Breast Cancer', 'Stage II Breast Cancer', 'Stage IIIA Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria).\n* Available tumor tissue for central review of HER2 status.\n* Planned surgical resection of breast tumor.\n* Planned neoadjuvant chemotherapy.\n* Documentation of HER2 gene amplification or overexpression.\n* Ipsilateral, measurable tumor longest diameter \\> 2 cm.\n* Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening).\n* ECOG performance status of 0 or 1.\n* Adequate bone marrow, hepatic and renal functions.\n* Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan.\n* Effective contraception as defined by protocol.\n\nKey Exclusion Criteria:\n\n* Investigational therapy within 2 months of first dose of study drug.\n* Bilateral breast cancer.\n* Inflammatory breast cancer\n* Metastases.\n* Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer.\n* Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug.\n* Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension.\n* Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug.\n* Pre-existing clinically significant Grade 2 peripheral neuropathy.\n* Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer).\n* Severe dyspnea at rest requiring oxygen therapy.\n* Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C.\n* Current pregnancy or breastfeeding.\n* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.'}, 'identificationModule': {'nctId': 'NCT03556358', 'briefTitle': 'Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanvex BioPharma USA, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer', 'orgStudyIdInfo': {'id': 'TX05-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TX05 (trastuzumab)', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles', 'interventionNames': ['Biological: TX05 (trastuzumab)', 'Drug: Paclitaxel', 'Drug: Epirubicin', 'Drug: Cyclophosphamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Herceptin®', 'description': '• Intravenous (IV) epirubicin, 75 mg/m\\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles\n\nFollowed by:\n\n• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles', 'interventionNames': ['Biological: Herceptin®', 'Drug: Paclitaxel', 'Drug: Epirubicin', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'TX05 (trastuzumab)', 'type': 'BIOLOGICAL', 'description': '8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)', 'armGroupLabels': ['TX05 (trastuzumab)']}, {'name': 'Herceptin®', 'type': 'BIOLOGICAL', 'description': '8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)', 'armGroupLabels': ['Herceptin®']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Ribotax'], 'description': '175 mg/m\\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)', 'armGroupLabels': ['Herceptin®', 'TX05 (trastuzumab)']}, {'name': 'Epirubicin', 'type': 'DRUG', 'description': '75 mg/m\\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)', 'armGroupLabels': ['Herceptin®', 'TX05 (trastuzumab)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '600 mg/m\\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)', 'armGroupLabels': ['Herceptin®', 'TX05 (trastuzumab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223040', 'city': 'Lyasny', 'state': 'Minsk Oblast', 'country': 'Belarus', 'facility': 'Tanvex Investigational Site 1008', 'geoPoint': {'lat': 54.0072, 'lon': 27.6963}}, {'zip': '213825', 'city': 'Babruysk', 'state': 'Mogilyov Oblast', 'country': 'Belarus', 'facility': 'Tanvex Investigational Site 1007', 'geoPoint': {'lat': 53.14636, 'lon': 29.20552}}, {'zip': '230017', 'city': 'Grodno', 'country': 'Belarus', 'facility': 'Tanvex Investigational Site 1006', 'geoPoint': {'lat': 53.62865, 'lon': 23.8942}}, {'zip': '246012', 'city': 'Homyel', 'country': 'Belarus', 'facility': 'Tanvex Investigational Site 1003', 'geoPoint': {'lat': 52.4345, 'lon': 30.9754}}, {'zip': '220013', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Tanvex Investigational Site 1002', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '2120018', 'city': 'Mogilev', 'country': 'Belarus', 'facility': 'Tanvex Investigational Site 1005', 'geoPoint': {'lat': 53.90876, 'lon': 30.34044}}, {'zip': '21008', 'city': 'Vitebsk', 'country': 'Belarus', 'facility': 'Tanvex Investigational Site 1001', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '4810469', 'city': 'Temuco', 'country': 'Chile', 'facility': 'Tanvex Investigational Site 4001', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'zip': '2520598', 'city': 'Viña del Mar', 'country': 'Chile', 'facility': 'Tanvex Investigational Site 4002', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '6000', 'city': 'Batumi', 'country': 'Georgia', 'facility': 'Tanvex Investigational Site 5006', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'zip': '6010', 'city': 'Batumi', 'country': 'Georgia', 'facility': 'Tanvex Investigational Site 5002', 'geoPoint': {'lat': 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