Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-01 @ 5:49 PM
Study NCT ID:
NCT01953003
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2013-08-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
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': 'C111217', 'term': 'vinflunine'}, {'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': 'Karim.keddad@pierre-fabre.com', 'phone': '+33.5.34.50.61.69', 'title': 'Karim Keddad, Head of Medical Unit', 'organization': 'Institut de Recherche Pierre Fabre, Toulouse France'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination of the study. Efficacy analyses were reduced to a descriptive summary of the primary efficacy variable (PFS) in the ITT population. This did not demonstrate any additional benefit of supplementing CAPE with VFL.\n\nAbbreviated CSR.'}}, 'adverseEventsModule': {'timeFrame': '3 years 3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A : iv Vinflunine Plus Capecitabine', 'description': 'Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.\n\nvinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²\n\nCapecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 54, 'seriousNumAtRisk': 56, 'deathsNumAffected': 26, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Arm B : Capecitabine', 'description': '1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest\n\nCapecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 46, 'seriousNumAtRisk': 55, 'deathsNumAffected': 32, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastroesophagal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'White blodd cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oedema pheripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neuropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypoaesthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Palmer-plantar erythrodysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pigmentation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oesopharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'ALAT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'ASAT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A : iv Vinflunine Plus Capecitabine', 'description': 'Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.\n\nvinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²\n\nCapecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²'}, {'id': 'OG001', 'title': 'Arm B : Capecitabine', 'description': '1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest\n\nCapecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²'}], 'classes': [{'categories': [{'title': 'Number of events (Participants)', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}, {'title': 'Number of censored observations (Participants)', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years', 'description': 'The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population, comprised of all randomised patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A : iv Vinflunine Plus Capecitabine', 'description': 'Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.\n\nvinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²\n\nCapecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²'}, {'id': 'FG001', 'title': 'Arm B : Capecitabine', 'description': '1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest\n\nCapecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Related Adverse events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-related adverse events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A : iv Vinflunine Plus Capecitabine', 'description': 'Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.\n\nvinflunine: intraveinous administration day 1 once every 3 weeks, 280 mg/m²\n\nCapecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²'}, {'id': 'BG001', 'title': 'Arm B : Capecitabine', 'description': '1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest\n\nCapecitabine: Arm A : 1650 mg/m² Arm B : 2500 mg/m²'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', '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 and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Singapore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Menopausal status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Menopausal', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Non-Menopausal', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumour site - primary cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Right Breast', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Left Breast', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-29', 'size': 359440, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-16T09:44', 'hasProtocol': True}, {'date': '2017-07-05', 'size': 1323155, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-17T03:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2013-08-13', 'resultsFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2013-09-25', 'lastUpdatePostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-29', 'studyFirstPostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years', 'description': 'The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Neoplasm of Breast']}, 'descriptionModule': {'briefSummary': 'Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. Capecitabine currently has a role in this setting, yet as many as 80% of patients do not respond to this treatment and those who respond eventually develop clinical resistance.\n\nThe antitumour activity of vinflunine has been demonstrated in patients with breast cancer after exposure to anthracycline and to taxane.\n\nVinflunine plus capecitabine has been shown to be a feasible combination for patients previously treated with an anthracycline and a taxane. Each drug in combination can be administered at efficacious doses.\n\nThis population has few therapeutic options with established clinical benefit. The development of a new regimen and potential new standard of care for this group is important.\n\n* Primary objective:\n\n • to compare in patients with advanced breast cancer pretreated with anthracycline and taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine alone, in terms of progression-free survival.\n* Secondary objectives:\n\n * to evaluate the response rate, the time to response and the duration of response in both arms\n * to compare the disease control rate between arms\n * to evaluate the duration of disease control in both arms\n * to evaluate the overall survival in both arms\n * to evaluate safety\n\nMethodology This multicentre, open-label, randomised, Phase III study will enrol a total of 334 patients with advanced breast cancer who have previously been treated with an anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus capecitabine (Arm A) or capecitabine alone (Arm B).', 'detailedDescription': 'RECIST 1.1 will be used for tumor assessment CTC - CAE version 3.0 will be used for safety assessment'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n1. Written informed consent\n2. Histologically or cytologically confirmed Her-2 negative carcinoma of the breast\n3. Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy\n4. One, two or three prior chemotherapy regimens including those administered in the neoadjuvant or adjuvant setting. At least one of the regimens must have been given for the treatment of advanced disease.\n5. Prior treatment must have included both an anthracycline and a taxane. minimum cumulative dose of 180 mg/m² of doxorubicin or of 300 mg/m² of epirubicin\n6. Documented progression on or within 12 months of the most recent chemotherapy.\n7. Prior hormone therapy is allowed\n8. Prior radiation therapy is allowed to less than 30% of the bone marrow\n9. LMeasurable or non measurable disease defined according to RECIST V1.1\n10. Adequate recovery from recent surgery\n11. Estimated life expectancy superior or equal of 12 weeks\n12. KPS equal or superior to 70%\n13. Age equal or superior to 21 years and \\< 80 years\n14. ANC) equal or superior to 1.5 x 109/L, platelet count equal or superior to 100 x109/L and haemoglobin \\> 10 g/dL.\n15. Bilirubin inferior or equal to 1.5 x upper limit of normal (ULN), AST and ALT inferior or equal to 2.5 x ULN or inferior or equal to 5 x ULN in the case of liver metastases, alkaline phosphatase inferior or equal to 5 x ULN.\n16. Calculated creatinine clearance superior or equal to 50 mL/min\n17. Normal ECG\n18. Patients on coumadin or warfarin must be on stable doses and INR inferior or equal to 3\n19. Women of childbearing potential must be using a medically accepted method of contraception. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration.\n20. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.\n\nEXCLUSION CRITERIA\n\n1. Known or with clinical evidence of brain metastasis or leptomeningeal involvement.\n2. Pulmonary lymphangitis or symptomatic pleural effusion (grade \\> 2) that results in pulmonary dysfunction requiring active treatment.\n3. Patients having received any other experimental drug or chemotherapy within 30 days\n4. History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years previously with no evidence of recurrence\n5. Pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade \\>1\n6. Patients having received \\> 3 regimens of chemotherapy\n7. Prior therapy with capecitabine and/or vinca-alkaloids\n8. History of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or any contra indication to any of the study drugs\n9. Known or suspected DPD\n10. Pregnant or lactating; With positive pregnancy test at inclusion\n11. Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment\n12. Known history of HIV infection\n13. Inability to take and/or absorb oral medication\n14. Any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation.\n15. Prior BMT or autologous stem cell infusion following high-dose chemotherapy.'}, 'identificationModule': {'nctId': 'NCT01953003', 'briefTitle': 'Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'A Multicenter, Randomised, Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously', 'orgStudyIdInfo': {'id': 'L00070 IN 311 B0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A : iv vinflunine plus Capecitabine', 'description': 'Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest.', 'interventionNames': ['Drug: vinflunine', 'Drug: Capecitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'capecitabineArm B : capecitabine', 'description': '1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest', 'interventionNames': ['Drug: Capecitabine']}], 'interventions': [{'name': 'vinflunine', 'type': 'DRUG', 'otherNames': ['Javlor'], 'description': 'intravenous administration day 1 once every 3 weeks, 280 mg/m²', 'armGroupLabels': ['Arm A : iv vinflunine plus Capecitabine']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['xeloda', 'from day 1 to day 14'], 'description': 'Arm A : 1650 mg/m² Arm B : 2500 mg/m²', 'armGroupLabels': ['Arm A : iv vinflunine plus Capecitabine', 'capecitabineArm B : capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Chengdu', 'country': 'China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Dalian', 'country': 'China', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Fuzhou', 'country': 'China', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Hangzhou', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Harbin', 'country': 'China', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Jinan', 'country': 'China', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Nanjing', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'country': 'China', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Tianjin', 'country': 'China', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Wuhan', 'country': 'China', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '119228', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'NUH', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '258500', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Gleneagles Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Binghe XU, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cancer Institute & Hospital. Chinese Academy of Medical Sciences, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}