Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-03 @ 11:55 PM
Study NCT ID:
NCT00130533
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2005-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'geicam@geicam.org', 'phone': '+34916592870', 'title': 'Scientific Director / Medical Lead / Project Manager', 'organization': 'Spanish Breast Cancer Research Group'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '5 years', 'eventGroups': [{'id': 'EG000', 'title': 'Xeloda (Capecitabine)', 'description': '1000 mgrs/m2 twice a day, tablets, 8 cycles\n\nCapecitabine', 'otherNumAtRisk': 436, 'deathsNumAtRisk': 448, 'otherNumAffected': 416, 'seriousNumAtRisk': 436, 'deathsNumAffected': 71, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Observation', 'description': 'Observation. No intervention.', 'otherNumAtRisk': 425, 'deathsNumAtRisk': 428, 'otherNumAffected': 271, 'seriousNumAtRisk': 425, 'deathsNumAffected': 73, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'LYMPHOPENIA', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'LYMPHOPENIA', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'LYMPHOPENIA', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'LYMPHOPENIA', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'BILIRUBIN', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'DIARRHEA', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'DIARRHEA', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'DIARRHEA', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'DIARRHEA', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'AST, SGOT', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'AST, SGOT', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'AST, SGOT', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'RENAL FAILURE', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'RENAL FAILURE', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'URIC ACID, SERUM-HIGH', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'URIC ACID, SERUM-HIGH', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'IRREGULAR MENSES', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 55}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'IRREGULAR MENSES', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'IRREGULAR MENSES', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'RASH: HAND-FOOT SKIN REACTION', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'RASH: HAND-FOOT SKIN REACTION', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'RASH: HAND-FOOT SKIN REACTION', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'LEUKOCYTES (TOTAL WBC)', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'LEUKOCYTES (TOTAL WBC)', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'LEUKOCYTES (TOTAL WBC)', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'NEUTROPHILS/GRANULOCYTES', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'NEUTROPHILS/GRANULOCYTES', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'NEUTROPHILS/GRANULOCYTES', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'FATIGUE', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'FATIGUE', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'FATIGUE', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'HEMOGLOBIN', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'HEMOGLOBIN', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'HEMOGLOBIN', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'NAUSEA', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'NAUSEA', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'NAUSEA', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'ALT, SGPT', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'ALT, SGPT', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'ALT, SGPT', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'NEUROPATHY: SENSORY', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'NEUROPATHY: SENSORY', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'NEUROPATHY: SENSORY', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}], 'seriousEvents': [{'term': 'Gastroenteritis and renal insuficience', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Supraventricular arrhythmia NOS', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Diarrhea', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Worsening of depressive syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Thoracic pain grade 2, disnea G-1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Infection with normal ANC ( Urinary)', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Neutropenia G 3; Leucopenia G2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'CNS cerebrovascular ischemia', 'notes': 'Grade 5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Hand-foot skin reaction', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Right renal colic', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Positive pregnant test performed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Mucositis Oral cavity and Pharynx', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Heart failure', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Thorax and left arm pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Infarction and cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Infection with unknown ANC pulmonary/upper respiratory - lung (pneumonia)', 'notes': 'Grade 5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Thrombosis/thrombus/embolism: venous thrombosis', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Ischemia cardiac/Infarction', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Axillary nodular resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Coronary vasospam', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Diarrhea grade 2, Vomiting grade 2, Septic shock grade 5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Showed lumbar column fracture(L4)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Dehydration', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Febrile neutropenia, Diarrhea, Hand foot skin reaction, Acute renal failure', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Pneumonia', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Ulcer gastric', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}, {'term': 'Hyperbilirrubinemia', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 436, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 425, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v. 3'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease Free Survival (DFS) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xeloda (Capecitabine)', 'description': '1000 mgrs/m2 twice a day, tablets, 8 cycles\n\nCapecitabine'}, {'id': 'OG001', 'title': 'Observation', 'description': 'Observation. No intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Free Survival (DFS) Events by Phenotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xeloda (Capecitabine)', 'description': '1000 mgrs/m2 twice a day, tablets, 8 cycles\n\nCapecitabine'}, {'id': 'OG001', 'title': 'Observation', 'description': 'Observation. No intervention.'}], 'classes': [{'categories': [{'title': 'Basal Phenotype', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}, {'title': 'Non basal Phenotype', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '428', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xeloda (Capecitabine)', 'description': '1000 mgrs/m2 twice a day, tablets, 8 cycles\n\nCapecitabine'}, {'id': 'OG001', 'title': 'Observation', 'description': 'Observation. No intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'OS event is defined as the death from any cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Who Experienced Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xeloda (Capecitabine)', 'description': '1000 mgrs/m2 twice a day, tablets, 8 cycles\n\nCapecitabine'}, {'id': 'OG001', 'title': 'Observation', 'description': 'Observation. No intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '416', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of toxicity was made in all study patients who had received at least 1 treatment cycle, or who had completed the observation period equivalent to 1 cycle.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xeloda (Capecitabine)', 'description': '1000 mgrs/m2 twice a day, tablets, 8 cycles\n\nCapecitabine'}, {'id': 'FG001', 'title': 'Observation', 'description': 'Observation. No intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '428'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '398'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Disease relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Interruption of treatment > 3 weeks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Sponsor´s decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Second Primary Malignancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Between October 2006 and September 2011, 876 patients were recruited, across 80 institutions in 8 countries (Spain, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, and Venezuela)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '428', 'groupId': 'BG001'}, {'value': '876', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Xeloda (Capecitabine)', 'description': '1000 mgrs/m2 twice a day, tablets, 8 cycles\n\nCapecitabine'}, {'id': 'BG001', 'title': 'Observation', 'description': 'Observation. No intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '79'}, {'value': '49', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '82'}, {'value': '49', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '448', 'groupId': 'BG000'}, {'value': '428', 'groupId': 'BG001'}, {'value': '876', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '313', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '622', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '532', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Ecuador', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Venezuela', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Karnofsky Index Performance Status', 'classes': [{'categories': [{'title': '80', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '90', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': '100', 'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '344', 'groupId': 'BG001'}, {'value': '727', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Karnofsky Scale allows patients to be classified as to their functional impairment. The lower the Karnofsky score, the worse the survival for most serious illnesses 100: Normal, no complaints 90: Minor signs or disease symptoms 80: Normal activity with effort 70: Care for self. Unable to carry on normal activity 60: Requires occasional assistance 50: Requires considerable assistance and frequent medical care 40: Disabled. Requires special care and assistance 30: Severly disabled 20: Very sick. Active supportive treatment necessary 10: Moribund 0: Dead', 'unitOfMeasure': 'Participants'}, {'title': 'Menopausal status at diagnosis', 'classes': [{'categories': [{'title': 'Premenopausal', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}, {'title': 'Postmenopausal', 'measurements': [{'value': '312', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histologic type', 'classes': [{'categories': [{'title': 'Invasive ductal carcinoma', 'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '764', 'groupId': 'BG002'}]}, {'title': 'Invasive lobular carcinoma', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histologic grade', 'classes': [{'categories': [{'title': 'Grade 1', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Grade 2', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Grade 3', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '622', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cancer cells are given a Grade (G) when they are removed from the breast and checked under a microscope. The G is based on how much the cancer cells look like normal cells.\n\n* G1 or well differentiated (score 3, 4, or 5): cells are slower-growing, and look more like normal breast tissue.\n* G2 or moderately differentiated (score 6, 7): cells are growing at a speed of and look like cells somewhere between G1 and 3.\n* G3 or poorly differentiated (score 8, 9): cells look very different from normal and will probably grow and spread faster.', 'unitOfMeasure': 'Participants'}, {'title': 'Phenotype by immunohistochemistry (IHC)', 'classes': [{'categories': [{'title': 'Basal', 'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '628', 'groupId': 'BG002'}]}, {'title': 'Non-basal', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Basal phenotype: Basal-like tumors receive this name because their genetic expression profile is similar to that of a normal basal epithelial cell. These similarities include the absence of expression of the estrogen receptor and other genes related with this and the human epidermal growth factor receptor 2 (HER2) receptor. They also share with the basal epithelial cells overexpression of cytokeratins 5/6 and 17, epidermal growth factor receptor (EGFR) and genes associated with proliferation. p53 mutations in thyrosine are also basal cell characteristics.', 'unitOfMeasure': 'Participants'}, {'title': 'Stage at diagnosis', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Stage II', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}, {'title': 'Stage III', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'According to American Joint Committee on Cancer (AJCC) 2002:\n\n* Stage (S) I: tumour \\<2 centimetres (cm)\n* S II:\n\nS IIA: cancer spread to movable ipsilateral axillary (MIA) Lymph Nodes (LN). tumor \\<2 cm and spread to MIA LN tumor \\>2 cm but \\>5 cm\n\nS IIB:\n\ntumor \\>2 cm but \\<5 cm and spread to MIA LN tumor \\>5 cm\n\n\\- S III: S IIIA: cancer spread to ipsilateral axillary LN fixed or matted S IIIB: tumor spread to the chest wall or caused swelling or ulceration of the breast or is diagnosed as inflammatory breast cancer.\n\nS IIIC: metastases in ipsilateral infraclavicular LN.', 'unitOfMeasure': 'Participants'}, {'title': 'Nodal status', 'classes': [{'categories': [{'title': 'Negative', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '486', 'groupId': 'BG002'}]}, {'title': '1-3 positive nodes', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}, {'title': '≥4 positive nodes', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Missing data', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of prior Chemotherapy', 'classes': [{'categories': [{'title': 'Adjuvant (only)', 'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '705', 'groupId': 'BG002'}]}, {'title': 'Neoadjuvant (+/- adjuvant)', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Missing data', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chemotherapy regimens', 'classes': [{'categories': [{'title': 'Anthracyclines-based', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}, {'title': 'Anthracyclines and taxanes-based', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '591', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Breast surgery', 'classes': [{'categories': [{'title': 'Conservative', 'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}]}, {'title': 'Mastectomy', 'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}, {'title': 'Missing data', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Axillary surgery', 'classes': [{'categories': [{'title': 'sentinel lymph node biopsy (SLNB)', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}, {'title': 'axillary lymph node dissection +/- SLNB', 'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'axillary lymph node dissection (ALND) sentinel lymph node biopsy (SLNB)', 'unitOfMeasure': 'Participants'}, {'title': 'Radiation therapy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '352', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '698', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2009-09-16', 'size': 768884, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-25T05:51', 'hasProtocol': True}, {'date': '2010-05-01', 'size': 186064, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-03T03:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 876}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2005-08-12', 'resultsFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2005-08-12', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-03', 'studyFirstPostDateStruct': {'date': '2005-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Free Survival (DFS) Events', 'timeFrame': '5 years', 'description': 'DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Disease Free Survival (DFS) Events by Phenotype', 'timeFrame': '5 years', 'description': 'DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.'}, {'measure': 'Overall Survival (OS) Event', 'timeFrame': '5 years', 'description': 'OS event is defined as the death from any cause.'}, {'measure': 'The Number of Participants Who Experienced Adverse Events (AE)', 'timeFrame': '5 years', 'description': 'Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).'}]}, 'conditionsModule': {'keywords': ['Triple-Negative Early Breast Cancer', 'Maintenance Adjuvant Chemotherapy', 'Capecitabine', 'Basal-like genotype', 'Triple-Negative'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '31804894', 'type': 'RESULT', 'citation': 'Lluch A, Barrios CH, Torrecillas L, Ruiz-Borrego M, Bines J, Segalla J, Guerrero-Zotano A, Garcia-Saenz JA, Torres R, de la Haba J, Garcia-Martinez E, Gomez HL, Llombart A, Bofill JS, Baena-Canada JM, Barnadas A, Calvo L, Perez-Michel L, Ramos M, Fernandez I, Rodriguez-Lescure A, Cardenas J, Vinholes J, Martinez de Duenas E, Godes MJ, Segui MA, Anton A, Lopez-Alvarez P, Moncayo J, Amorim G, Villar E, Reyes S, Sampaio C, Cardemil B, Escudero MJ, Bezares S, Carrasco E, Martin M; GEICAM Spanish Breast Cancer Group; CIBOMA (Iberoamerican Coalition for Research in Breast Oncology); LACOG (Latin American Cooperative Oncology Group). Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01). J Clin Oncol. 2020 Jan 20;38(3):203-213. doi: 10.1200/JCO.19.00904. Epub 2019 Dec 5.'}, {'pmid': '33397968', 'type': 'RESULT', 'citation': 'Schettini F, Chic N, Braso-Maristany F, Pare L, Pascual T, Conte B, Martinez-Saez O, Adamo B, Vidal M, Barnadas E, Fernandez-Martinez A, Gonzalez-Farre B, Sanfeliu E, Cejalvo JM, Perrone G, Sabarese G, Zalfa F, Peg V, Fasani R, Villagrasa P, Gavila J, Barrios CH, Lluch A, Martin M, Locci M, De Placido S, Prat A. Clinical, pathological, and PAM50 gene expression features of HER2-low breast cancer. NPJ Breast Cancer. 2021 Jan 4;7(1):1. doi: 10.1038/s41523-020-00208-2.'}, {'pmid': '36346687', 'type': 'RESULT', 'citation': 'Asleh K, Lluch A, Goytain A, Barrios C, Wang XQ, Torrecillas L, Gao D, Ruiz-Borrego M, Leung S, Bines J, Guerrero-Zotano A, Garcia-Saenz JA, Cejalvo JM, Herranz J, Torres R, Haba-Rodriguez J, Ayala F, Gomez H, Rojo F, Nielsen TO, Martin M. Triple-Negative PAM50 Non-Basal Breast Cancer Subtype Predicts Benefit from Extended Adjuvant Capecitabine. Clin Cancer Res. 2023 Jan 17;29(2):389-400. doi: 10.1158/1078-0432.CCR-22-2191.'}, {'pmid': '35279130', 'type': 'RESULT', 'citation': 'Ye F, Bian L, Wen J, Yu P, Li N, Xie X, Wang X. Additional capecitabine use in early-stage triple negative breast cancer patients receiving standard chemotherapy: a new era? A meta-analysis of randomized controlled trials. BMC Cancer. 2022 Mar 12;22(1):261. doi: 10.1186/s12885-022-09326-5.'}], 'seeAlsoLinks': [{'url': 'http://www.ciboma.org/', 'label': "Sponsor's web"}, {'url': 'http://www.geicam.org/', 'label': 'Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-label, randomized phase III study assessing adjuvant capecitabine after standard chemotherapy for patients with early triple negative breast cancer.', 'detailedDescription': 'Patients will be stratified as per investigational site, previous adjuvant chemotherapy (anthracyclines versus anthracyclines plus taxanes), and number of affected axillary lymph nodes (0, 1-3, \\>= 4). Node negative patients must present a tumour size \\> 2 cm to be eligible. At least 6 lymph nodes must be analysed to confirm the number of affected nodes. Patients will be randomised to receive: 8 courses of capecitabine 1000 mg/m2 by mouth, twice a day (p.o. bid) for 14 days, followed by a 7 day rest versus observation.\n\nTissue samples must be analysed by a central laboratory, to confirm estrogen receptor (ER), progesterone receptor (PgR), human epidermal growth factor receptor-2 (HER2), cytokeratins (CK) 5/6 and epidermal growth factor receptor (EGFR) status.\n\nThe following data were obtained from the database of the "El Alamo" project. One thousand six hundred and twenty-seven (1,627) in total were considered during the years 1990 to 1997. The population is formed of patients with operable breast cancer, with surgery, positive nodes, and negative hormone receptors, or negative nodes, negative hormone receptors and T2-3 tumors.\n\nFor these patient groups, estimated 5-year disease-free survival is 64.72%. Assuming an exponential distribution, the aim is to detect an increase of 64.72% to 73.7% in 5 years Disease Free survival rate corresponds to a Hazard Ratio of 0.701 and a risk reduction of about 30%, with a power of 80% using a two-tailed log-rank test at 0.05 and whereas 4 years of recruitment period and 3 years of follow-up period. We would need 255 events, 834 patients without considering any dropouts.\n\nConsidering a drop-out rate of 5% post-randomization, the final sample size will be 876 patients, 438 per treatment arm.\n\nThe sample size calculation was performed by the program package "EAST" version 5.2.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent.\n* Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between end of adjuvant chemotherapy and study randomization must be less than 8 weeks. In patients receiving adjuvant radiotherapy, time window allowed between last session and randomisation is 4 weeks.\n* Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinoma in-situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.\n* Node negative patients with tumour size \\> 2 cm.\n* Positive axillary lymph nodes defined as at least 1 out of 6 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: pN1a (Metastases in 1-3 axillary lymph nodes, at least one metastasis greater than 2.0 mm), pN2a (Metastases in 4-9 axillary lymph nodes (at least one tumor deposit greater than 2 mm)), pN3a (Metastases in 10 or more axillary lymph nodes \\[at least one tumor deposit greater than 2 mm\\]; or metastases to the infraclavicular \\[level III axillary lymph\\] nodes).\n* Status of hormone receptors in primary tumour. Negative results must be available before the end of adjuvant chemotherapy.\n* Patients must not present evidence of metastatic disease.\n* Negative status of HER2 in primary tumour, known before randomization.\n* Adjuvant chemotherapy consisting of a minimum of 6 courses with anthracyclines and/or taxanes.\n* Age \\>= 18 and \\<= 70 years old.\n* Performance status (Karnofsky index) \\>= 80.\n* Laboratory results (within 14 days prior to randomization):\n* Hematology:\n\n * neutrophils \\>= 1.5 x 10e9/l;\n * platelets \\>= 100x 10e9/l;\n * hemoglobin \\>= 10 mg/dl\n* Hepatic function:\n\n * total bilirubin \\<= 1 upper normal limit (UNL);\n * Aspartate aminotransferase (AST or SGOT) and Alanine aminotransferase (ALT or SGPT) \\<= 2.5 UNL;\n * alkaline phosphatase \\<= 2.5 UNL.\n * If values of SGOT and SGPT \\> 1.5 UNL are associated to alkaline phosphatase \\> 2.5 UNL, patient is not eligible.\n* Renal Function:\n\n * creatinine \\<= 175 µmol/l (2 mg/dl).\n * creatinine clearance \\>= 60 ml/min.\n* Pharmacogenetics:\n\n * one blood sample is needed for single nucleotide polymorphism (SNP) assessment.\n* Patients able to comply with treatment and study follow-up.\n* Negative pregnancy test done in the 14 previous days to randomization.\n\nExclusion Criteria:\n\n* Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.\n* Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.\n* Bilateral invasive breast cancer.\n* Any T4 or M1 tumour.\n* Axillary lymph nodes: patients belonging to the following classifications are excluded: pN1b (Metastases in internal mammary nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN1c (Metastases in 1-3 axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN2b (Metastases in clinically detected internal mammary lymph nodes in the absence of axillary lymph node metastases), pN3b (Metastases in clinically detected ipsilateral internal mammary lymph nodes in the presence of one or more positive axillary lymph nodes; or in more than three axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN3c (Metastases in ipsilateral supraclavicular lymph nodes).\n* Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.\n* History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.\n* Active uncontrolled infection.\n* Active peptic ulcer, unstable diabetes mellitus.\n* Previous or current history of neoplasms different to breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.\n* History of hypersensitivity to capecitabine, fluorouracil.\n* Patients lacking physical integrity of upper gastrointestinal tract or with history of bad absorption syndrome.\n* History of dihydropyrimidine dehydrogenase (DPD) deficiency.\n* Anticoagulant treatment with coumadin anticoagulants.\n* Current treatment with sorivudine or its chemical family.\n* Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.\n* Concomitant treatment with other therapy for cancer.\n* Males.'}, 'identificationModule': {'nctId': 'NCT00130533', 'briefTitle': 'Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Breast Cancer Research Group'}, 'officialTitle': 'Multicenter, Open-label, Randomized Phase III to Evaluate Efficacy of Maintenance Treatment With Capecitabine Following Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'CIBOMA 2004-01'}, 'secondaryIdInfos': [{'id': '2005-002838-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xeloda (capecitabine)', 'description': '1000 mgrs/m2 twice a day, tablets, 8 cycles', 'interventionNames': ['Drug: Capecitabine']}, {'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'Observation. No intervention.'}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'armGroupLabels': ['Xeloda (capecitabine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03203', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': "Instituto Catalán de Oncología de L'Hospitalet", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporació Sanitaria Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08923', 'city': 'Santa Coloma de Gramenet', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Espíritu Santo', 'geoPoint': {'lat': 41.45152, 'lon': 2.2081}}, {'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '12002', 'city': 'Castellon', 'state': 'Castellón', 'country': 'Spain', 'facility': 'Hospital Provincial de Castellón', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '11407', 'city': 'Jerez de la Frontera', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital General de Jerez', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'zip': '20012', 'city': 'Donostia / San Sebastian', 'state': 'Guipúzcoa', 'country': 'Spain', 'facility': 'Onkologikoa', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '20014', 'city': 'Donostia / San Sebastian', 'state': 'Guipúzcoa', 'country': 'Spain', 'facility': 'Hospital de Donostia', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '22300', 'city': 'Barbastro', 'state': 'Huesca', 'country': 'Spain', 'facility': 'Hospital de Barbastro', 'geoPoint': {'lat': 42.03565, 'lon': 0.12686}}, {'zip': '35016', 'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'country': 'Spain', 'facility': 'Hospital Insular de Las Palmas de Gran Canaria', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Alcorcón', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '28703', 'city': 'San Sebastián de los Reyes', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Coalición Iberoamericana de Investigación en Oncología Mamaria (CIBOMA)', 'geoPoint': {'lat': 40.55555, 'lon': -3.62733}}, {'zip': '36312', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15009', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Centro Oncológico de Galicia', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario General de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario Germans Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '09006', 'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital Universitario General Yagüe', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '11009', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '19002', 'city': 'Guadalajara', 'country': 'Spain', 'facility': 'Hospital General Universitario de Guadalajara', 'geoPoint': {'lat': 40.62862, 'lon': -3.16185}}, {'zip': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Universitario Arnau de Vilanova de Lleida', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28021', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ruber Internacional', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de Madrid Norte Sanchinarro (CIOCC)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30120', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '30008', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital General Universitario Morales Meseguer', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '32005', 'city': 'Ourense', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario Nuestra Señora de Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de la Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '49021', 'city': 'Zamora', 'country': 'Spain', 'facility': 'Hospital Provincial de Zamora "Rodríguez Chamorro"', 'geoPoint': {'lat': 41.50633, 'lon': -5.74456}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Zaragoza "Lozano Blesa"', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Study Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínico Universitario de Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Breast Cancer Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, {'name': 'IBEROAMERICAN COALITION FOR BREAST ONCOLOGY RESEARCH (CIBOMA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}