Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-16 @ 11:10 PM
Study NCT ID:
NCT00127933
Status:
COMPLETED
Last Update Posted:
2011-08-10
First Post:
2005-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, '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': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': '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': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffman-LaRoche'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Cycle 1, Cycle 2, Cycle 3, Cycle 4, at Surgery, and the month 1 visit during the postoperative follow-up period', 'description': 'Intensity of AEs was graded according to the NCI CTCAE version 3.0 on a 5-point scale (grade 1 to 5), clinical laboratory parameters (hematology, chemistry, and urinalysis as clinically indicated), and vital signs.', 'eventGroups': [{'id': 'EG000', 'title': 'HER2-Neu Negative', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1\n\nHER2-neu negative: capecitabine + docetaxel\n\nDuration: Four 3-week treatment cycles', 'otherNumAtRisk': 122, 'otherNumAffected': 121, 'seriousNumAtRisk': 122, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'HER2-Neu Positive', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly\n\nHER2-neu positive: capecitabine + docetaxel + trastuzumab\n\nDuration: Four 3-week treatment cycles', 'otherNumAtRisk': 34, 'otherNumAffected': 33, 'seriousNumAtRisk': 34, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Catheter site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Prothrombin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2-Neu Negative', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1\n\nHER2-neu negative: capecitabine + docetaxel\n\nDuration: Four 3-week treatment cycles'}, {'id': 'OG001', 'title': 'HER2-Neu Positive', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly\n\nHER2-neu positive: capecitabine + docetaxel + trastuzumab\n\nDuration: Four 3-week treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '25.4'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '31.9', 'upperLimit': '71.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the time of definitive surgery; after four 3-week cycles (3-4 months)', 'description': 'Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pathological Response Evaluable Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2-Neu Negative', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1\n\nHER2-neu negative: capecitabine + docetaxel\n\nDuration: Four 3-week treatment cycles'}, {'id': 'OG001', 'title': 'HER2-Neu Positive', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly\n\nHER2-neu positive: capecitabine + docetaxel + trastuzumab\n\nDuration: Four 3-week treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '18.1'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '57.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the time of definitive surgery; after four 3-week cycles (3-4 months)', 'description': 'Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pathological Response Evaluable Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2-Neu Negative', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1\n\nHER2-neu negative: capecitabine + docetaxel\n\nDuration: Four 3-week treatment cycles'}, {'id': 'OG001', 'title': 'HER2-Neu Positive', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly\n\nHER2-neu positive: capecitabine + docetaxel + trastuzumab\n\nDuration: Four 3-week treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '35.9'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '45.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'post 2 and 4, 3-week cycles of treatment', 'description': 'The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Local Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2-Neu Negative', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1\n\nHER2-neu negative: capecitabine + docetaxel\n\nDuration: Four 3-week treatment cycles'}, {'id': 'OG001', 'title': 'HER2-Neu Positive', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly\n\nHER2-neu positive: capecitabine + docetaxel + trastuzumab\n\nDuration: Four 3-week treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '8.7'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '19.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 - 1102 days', 'description': 'Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Postoperative Response Evaluable Population'}, {'type': 'SECONDARY', 'title': 'Participants With Disease-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2-Neu Negative', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1\n\nHER2-neu negative: capecitabine + docetaxel\n\nDuration: Four 3-week treatment cycles'}, {'id': 'OG001', 'title': 'HER2-Neu Positive', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly\n\nHER2-neu positive: capecitabine + docetaxel + trastuzumab\n\nDuration: Four 3-week treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 - 1102 days', 'description': 'Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Postoperative Response Evaluable Population.'}, {'type': 'SECONDARY', 'title': 'Participants With Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2-Neu Negative', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1\n\nHER2-neu negative: capecitabine + docetaxel\n\nDuration: Four 3-week treatment cycles'}, {'id': 'OG001', 'title': 'HER2-Neu Positive', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly\n\nHER2-neu positive: capecitabine + docetaxel + trastuzumab\n\nDuration: Four 3-week treatment cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '22 - 1191 days', 'description': 'Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the post-operative Response Evaluable Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HER2-Neu Negative', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1\n\nHER2-neu negative: capecitabine + docetaxel\n\nDuration: Four 3-week treatment cycles'}, {'id': 'FG001', 'title': 'HER2-Neu Positive', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly\n\nHER2-neu positive: capecitabine + docetaxel + trastuzumab\n\nDuration: Four 3-week treatment cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Pathological Response', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Clinical Response', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Quality of Life Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Postoperative', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomized but not dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HER2-Neu Negative', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1\n\nHER2-neu negative: capecitabine + docetaxel\n\nDuration: Four 3-week treatment cycles'}, {'id': 'BG001', 'title': 'HER2-Neu Positive', 'description': 'Dose and route per treatment cycle (Q3W):\n\nCapecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly\n\nHER2-neu positive: capecitabine + docetaxel + trastuzumab\n\nDuration: Four 3-week treatment cycles'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '11.20', 'groupId': 'BG000'}, {'value': '52.2', 'spread': '9.36', 'groupId': 'BG001'}, {'value': '51.3', 'spread': '10.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Safety Population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '156', '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-13', 'studyFirstSubmitDate': '2005-08-05', 'resultsFirstSubmitDate': '2011-03-30', 'studyFirstSubmitQcDate': '2005-08-05', 'lastUpdatePostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-13', 'studyFirstPostDateStruct': {'date': '2005-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery', 'timeFrame': 'at the time of definitive surgery; after four 3-week cycles (3-4 months)', 'description': 'Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Near pCR (npCR) was defined as the presence of invasive tumor cells with a size of 5 mm or less in aggregate in the tissue specimen removed from the breast after 4 cycles of preoperative treatment. Only pathological assessments occurring prior to the first date of adjuvant treatment were included in the analysis of pCR rate.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery', 'timeFrame': 'at the time of definitive surgery; after four 3-week cycles (3-4 months)', 'description': 'Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.'}, {'measure': 'Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))', 'timeFrame': 'post 2 and 4, 3-week cycles of treatment', 'description': 'The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.'}, {'measure': 'Percentage of Participants With Local Recurrence', 'timeFrame': '30 - 1102 days', 'description': 'Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.'}, {'measure': 'Participants With Disease-Free Survival', 'timeFrame': '30 - 1102 days', 'description': 'Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.'}, {'measure': 'Participants With Overall Survival', 'timeFrame': '22 - 1191 days', 'description': 'Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration \\[po\\] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women \\>=18 years of age;\n* newly diagnosed;\n* infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.\n\nExclusion Criteria:\n\n* evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;\n* previous systemic or local primary treatment.'}, 'identificationModule': {'nctId': 'NCT00127933', 'briefTitle': 'XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-label Study of Xeloda Plus Taxotere on Treatment Response in Patients With HER2-neu-negative, and the Addition of Herceptin for HER2-neu-positive Breast Cancer', 'orgStudyIdInfo': {'id': 'ML18530'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HER2-NEU Positive', 'interventionNames': ['Drug: capecitabine [Xeloda]', 'Drug: Taxotere', 'Drug: Herceptin (HER2-neu positive patients only)']}, {'type': 'EXPERIMENTAL', 'label': 'HER2-NEU Negative', 'interventionNames': ['Drug: capecitabine [Xeloda]', 'Drug: Taxotere']}], 'interventions': [{'name': 'capecitabine [Xeloda]', 'type': 'DRUG', 'description': '825mg/m2 po bid on days 1-14 of each 3 week cycle', 'armGroupLabels': ['HER2-NEU Positive']}, {'name': 'Taxotere', 'type': 'DRUG', 'description': '75mg/m2 iv on day 1 of each 3 week cycle', 'armGroupLabels': ['HER2-NEU Positive']}, {'name': 'Herceptin (HER2-neu positive patients only)', 'type': 'DRUG', 'description': '4mg/kg iv (loading dose) followed by 2mg/kg iv weekly', 'armGroupLabels': ['HER2-NEU Positive']}, {'name': 'capecitabine [Xeloda]', 'type': 'DRUG', 'description': '825mg/m2 po bid on days 1-14 of each 3 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