Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-06 @ 8:13 AM
Study NCT ID:
NCT02162667
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Croatia', 'Ecuador', 'Greece', 'Serbia', 'Thailand', 'Turkey (Türkiye)']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'contact@celltrion.com', 'phone': '82328505000', 'title': 'Head of Clinical Planning Department', 'organization': 'Celltrion'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed from the date the informed consent form is signed until up to 30 days from last dose of study drug, regardless of the relationship to the study drug', 'eventGroups': [{'id': 'EG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)', 'otherNumAtRisk': 271, 'otherNumAffected': 263, 'seriousNumAtRisk': 271, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).', 'otherNumAtRisk': 278, 'otherNumAffected': 264, 'seriousNumAtRisk': 278, 'seriousNumAffected': 36}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 67}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 41}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 116}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 15}], 'organSystem': 'Eye disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 94}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 38}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 62}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 18}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 30}], 'organSystem': 'General disorders'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 8}], 'organSystem': 'Infections and infestations'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 28}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 34}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 30}], 'organSystem': 'Investigations'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 25}], 'organSystem': 'Investigations'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 9}], 'organSystem': 'Investigations'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 13}], 'organSystem': 'Investigations'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 40}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 8}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 21}], 'organSystem': 'Nervous system disorders'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 20}], 'organSystem': 'Nervous system disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 196}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 213}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 11}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Adams-Stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Implant site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Incarcerated hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Septic embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Complications of transplant surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Pneumothorax traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Heart rate irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Neurodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Oocyte harvest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.77', 'groupId': 'OG000', 'lowerLimit': '40.43', 'upperLimit': '53.19'}, {'value': '50.39', 'groupId': 'OG001', 'lowerLimit': '44.10', 'upperLimit': '56.68'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After Neo-adjuvant therapy and Surgery (up to 30 weeks)', 'description': 'Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.\n\nThe primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.84', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '8.30'}, {'value': '4.69', 'groupId': 'OG001', 'lowerLimit': '2.45', 'upperLimit': '8.04'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After Neo-adjuvant therapy and Surgery (up to 30 weeks)', 'description': 'Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.\n\nThe secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.92', 'groupId': 'OG000', 'lowerLimit': '33.78', 'upperLimit': '46.31'}, {'value': '41.41', 'groupId': 'OG001', 'lowerLimit': '35.31', 'upperLimit': '47.71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After Neo-adjuvant therapy and Surgery (up to 30 weeks)', 'description': 'Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.\n\nThe secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) From Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.27', 'groupId': 'OG000', 'lowerLimit': '79.14', 'upperLimit': '88.57'}, {'value': '83.98', 'groupId': 'OG001', 'lowerLimit': '78.91', 'upperLimit': '88.26'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After Neo-adjuvant therapy (up to 24 weeks)', 'description': 'The ORR was defined as the proportion of patients with a BOR of CR or PR as assessed by RECIST guideline Version 1.1 during the Nedadjuvant Period.', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).'}], 'classes': [{'title': '1 year', 'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '0.97'}, {'value': '0.96', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '0.98'}]}]}, {'title': '2 years', 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '0.90'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.85', 'upperLimit': '0.92'}]}]}, {'title': '3 years', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '0.87'}, {'value': '0.82', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '0.88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years from the day of last patient enrollment (during whole study period)', 'description': 'Patients who underwent breast surgery were included in the DFS analysis. Disease-free survival was defined as the interval between the date of breast surgery and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}], 'classes': [{'title': '1 year', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.00'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.95', 'upperLimit': '0.99'}]}]}, {'title': '2 years', 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '0.94'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.89', 'upperLimit': '0.95'}]}]}, {'title': '3 years', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '0.87'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.82', 'upperLimit': '0.90'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years from the day of last patient enrollment (during whole study period)', 'description': 'Progression-free survival was defined as the interval between randomization and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}], 'classes': [{'title': '1 year', 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.97', 'upperLimit': '1.00'}]}]}, {'title': '2 years', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '0.99'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '0.99'}]}]}, {'title': '3 years', 'categories': [{'measurements': [{'value': '0.95', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '0.97'}, {'value': '0.94', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '0.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years from the day of last patient enrollment (during whole study period)', 'description': 'Overall survival was defined as the interval between randomization and death from any cause.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'The Number of Patients Who Had Progressive Disease or Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}], 'classes': [{'title': 'Overall Period', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Neoadjuvant Period', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Adjuvant Period', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Period', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years from the day of last patient enrollment (during whole study period)', 'description': 'If recurrence or progression of disease occurred at any time during the study, the progressed tumor site was recorded in the "recurrence or progression of disease" eCRF page as local, regional, or distant, with diagnostic method and whether positive cytology or histology or not.\n\nThe resulting recurrence or progression of disease information was summarized as secondary endpoint.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration After Administration (Cmax) in Each Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '186.428', 'spread': '69.0828', 'groupId': 'OG000'}, {'value': '178.567', 'spread': '55.3800', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '145.078', 'spread': '47.7899', 'groupId': 'OG000'}, {'value': '138.989', 'spread': '45.7103', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '145.183', 'spread': '44.5392', 'groupId': 'OG000'}, {'value': '141.130', 'spread': '43.8189', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '148.541', 'spread': '54.2737', 'groupId': 'OG000'}, {'value': '137.465', 'spread': '45.6914', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '136.210', 'spread': '44.6078', 'groupId': 'OG000'}, {'value': '135.307', 'spread': '47.1950', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '143.569', 'spread': '42.4510', 'groupId': 'OG000'}, {'value': '143.605', 'spread': '51.2868', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '146.726', 'spread': '48.0249', 'groupId': 'OG000'}, {'value': '141.468', 'spread': '43.1823', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '145.081', 'spread': '41.5382', 'groupId': 'OG000'}, {'value': '144.238', 'spread': '57.3618', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of each treatment cycles, up to 24 weeks (during neoadjuvant period)', 'description': 'Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All patients randomly assigned to study drug and who receive at least 1 dose (fully or partially) of study drug'}, {'type': 'SECONDARY', 'title': 'Trough Serum Concentration (Ctrough) in Each Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8.'}], 'classes': [{'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '18.915', 'spread': '22.9964', 'groupId': 'OG000'}, {'value': '18.905', 'spread': '21.2967', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'categories': [{'measurements': [{'value': '17.346', 'spread': '17.9771', 'groupId': 'OG000'}, {'value': '16.773', 'spread': '16.8134', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'categories': [{'measurements': [{'value': '16.796', 'spread': '17.2409', 'groupId': 'OG000'}, {'value': '17.816', 'spread': '23.3438', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'categories': [{'measurements': [{'value': '17.851', 'spread': '20.1572', 'groupId': 'OG000'}, {'value': '15.904', 'spread': '15.8754', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'categories': [{'measurements': [{'value': '18.403', 'spread': '19.9042', 'groupId': 'OG000'}, {'value': '17.962', 'spread': '17.9429', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'categories': [{'measurements': [{'value': '18.902', 'spread': '20.2198', 'groupId': 'OG000'}, {'value': '18.256', 'spread': '17.6964', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7', 'categories': [{'measurements': [{'value': '18.540', 'spread': '14.3313', 'groupId': 'OG000'}, {'value': '18.718', 'spread': '18.5976', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'categories': [{'measurements': [{'value': '17.901', 'spread': '7.2203', 'groupId': 'OG000'}, {'value': '17.129', 'spread': '10.0491', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion of cycles 1 to 8 during neoadjuvant period', 'description': 'Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All patients randomly assigned to study drug and who receive at least 1 dose (fully or partially) of study drug'}, {'type': 'POST_HOC', 'title': 'The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes Regardless of DCIS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}, {'id': 'OG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.61', 'groupId': 'OG000', 'lowerLimit': '45.20', 'upperLimit': '57.98'}, {'value': '55.08', 'groupId': 'OG001', 'lowerLimit': '48.76', 'upperLimit': '61.28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After Neo-adjuvant therapy and Surgery (up to 30 weeks)', 'description': 'Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.\n\nThe secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)'}, {'id': 'FG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).'}], 'periods': [{'title': 'Neoadjuvant Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '284'}]}, {'type': 'COMPLETED', 'comment': 'the number of patients who completed 8 cycles of the Neoadjuvant Period and underwent surgery.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '267'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}, {'title': 'Adjuvant Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '268'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '255'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CT-P6', 'description': 'Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).'}, {'id': 'BG001', 'title': 'Herceptin', 'description': 'Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m\\^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m\\^2, epirubicin 75mg/m\\^2, and cyclophosphamide 500mg/m\\^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '79'}, {'value': '52.5', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '74'}, {'value': '53.0', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '278', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 562}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2014-06-11', 'resultsFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2014-06-11', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-09', 'studyFirstPostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)', 'timeFrame': 'After Neo-adjuvant therapy and Surgery (up to 30 weeks)', 'description': 'Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.\n\nThe primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status', 'timeFrame': 'After Neo-adjuvant therapy and Surgery (up to 30 weeks)', 'description': 'Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.\n\nThe secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.'}, {'measure': 'The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS', 'timeFrame': 'After Neo-adjuvant therapy and Surgery (up to 30 weeks)', 'description': 'Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.\n\nThe secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.'}, {'measure': 'Overall Response Rate (ORR) From Local Review', 'timeFrame': 'After Neo-adjuvant therapy (up to 24 weeks)', 'description': 'The ORR was defined as the proportion of patients with a BOR of CR or PR as assessed by RECIST guideline Version 1.1 during the Nedadjuvant Period.'}, {'measure': 'Disease-free Survival', 'timeFrame': 'Up to 3 years from the day of last patient enrollment (during whole study period)', 'description': 'Patients who underwent breast surgery were included in the DFS analysis. Disease-free survival was defined as the interval between the date of breast surgery and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.'}, {'measure': 'Progression-Free Survival', 'timeFrame': 'Up to 3 years from the day of last patient enrollment (during whole study period)', 'description': 'Progression-free survival was defined as the interval between randomization and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 3 years from the day of last patient enrollment (during whole study period)', 'description': 'Overall survival was defined as the interval between randomization and death from any cause.'}, {'measure': 'The Number of Patients Who Had Progressive Disease or Recurrence', 'timeFrame': 'Up to 3 years from the day of last patient enrollment (during whole study period)', 'description': 'If recurrence or progression of disease occurred at any time during the study, the progressed tumor site was recorded in the "recurrence or progression of disease" eCRF page as local, regional, or distant, with diagnostic method and whether positive cytology or histology or not.\n\nThe resulting recurrence or progression of disease information was summarized as secondary endpoint.'}, {'measure': 'Maximum Serum Concentration After Administration (Cmax) in Each Cycle', 'timeFrame': 'End of each treatment cycles, up to 24 weeks (during neoadjuvant period)', 'description': 'Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.'}, {'measure': 'Trough Serum Concentration (Ctrough) in Each Cycle', 'timeFrame': 'Pre-infusion of cycles 1 to 8 during neoadjuvant period', 'description': 'Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HER2-positive Carcinoma of Breast']}, 'referencesModule': {'references': [{'pmid': '34148205', 'type': 'DERIVED', 'citation': 'Stebbing J, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Pikiel J, Eniu AE, Li RK, Tiangco B, Lee SJ, Kim S. Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial. Breast Cancer Res Treat. 2021 Aug;188(3):631-640. doi: 10.1007/s10549-021-06240-5. Epub 2021 Jun 20.'}, {'pmid': '31428820', 'type': 'DERIVED', 'citation': 'Esteva FJ, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Stroyakovskiy D, Pikiel J, Eniu AE, Li RK, Rusyn AV, Tiangco B, Lee SJ, Lee SY, Yu SY, Stebbing J. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial. Cancer Chemother Pharmacol. 2019 Oct;84(4):839-847. doi: 10.1007/s00280-019-03920-4. Epub 2019 Aug 19.'}, {'pmid': '28592386', 'type': 'DERIVED', 'citation': 'Stebbing J, Baranau Y, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Stroyakovskii D, Pikiel J, Eniu A, Komov D, Morar-Bolba G, Li RK, Rusyn A, Lee SJ, Lee SY, Esteva FJ. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017 Jul;18(7):917-928. doi: 10.1016/S1470-2045(17)30434-5. Epub 2017 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy. Our hypothesis is that the pathologic complete response rate will be equivalent in patients treated with neoadjuvant CT-P6 or Herceptin. Patients will receive 8 cycles of neoadjuvant systemic therapy and up to 10 cycles of therapy in the adjuvant setting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who has histologically confirmed and newly diagnosed breast cancer\n* Patient who has clinical stage I, II, or IIIa operable breast cancer according to AJCC (American Joint Committee on Cancer) Breast Cancer Staging 7th edition\n* Patient who has HER2-positive status confirmed locally, defined as 3+ score by IHC (immuno-histochemistry).\n\nExclusion Criteria:\n\n* Patient who has bilateral breast cancer\n* Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.'}, 'identificationModule': {'nctId': 'NCT02162667', 'briefTitle': 'Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'Phase 3 Efficacy and Safety Study of CT-P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients With Her2-positive Early Breast Cancer', 'orgStudyIdInfo': {'id': 'CT-P6 3.2'}, 'secondaryIdInfos': [{'id': '2013-004525-84', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-P6', 'interventionNames': ['Drug: Trastuzumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trastuzumab', 'interventionNames': ['Drug: Trastuzumab']}], 'interventions': [{'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': 'Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.', 'armGroupLabels': ['CT-P6', 'Trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1185', 'city': 'Buenos Aires', 'country': 'Argentina', 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