Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01298193
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2011-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early 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': 'D000077608', 'term': 'Aprepitant'}, {'id': 'D058831', 'term': 'Serotonin 5-HT3 Receptor Antagonists'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'D004329', 'term': 'Droperidol'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'C033968', 'term': 'alizapride'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D004294', 'term': 'Domperidone'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012702', 'term': 'Serotonin Antagonists'}, {'id': 'D018490', 'term': 'Serotonin Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'geicam@geicam.org', 'phone': '+34916592870', 'title': 'Scientific Director / Medical Lead / Project Manager', 'organization': 'Spanish Breast Cancer Research Group'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study treatment, average of 6 weeks', 'description': 'This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Observational Phase (First Cycle):', 'description': 'Day 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).', 'otherNumAtRisk': 185, 'deathsNumAtRisk': 185, 'otherNumAffected': 47, 'seriousNumAtRisk': 185, 'deathsNumAffected': 1, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Efficacy Phase (Second Cycle):', 'description': 'Day 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg).\n\nChemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg).', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 22, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Vomiting', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Nausea', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Vomiting', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Nausea', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Vomiting', 'notes': 'Grade 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}], 'seriousEvents': [{'term': 'Anemic Shock', 'notes': 'Grade 5', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Febrile Neutropenia', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Colon Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Vomiting', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Febrile neutropenia', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Lower Gastrointestinal Bleeding', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Mucositis', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Erythema with pruritus and skin lessions', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Enterocollitis', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Neutrophil Count Decreased', 'notes': 'Grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Neutrophil Count Decreased', 'notes': 'Grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}, {'term': 'Neutrophil Count Decreased', 'notes': 'Grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTC version 4.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Complete Response (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observational Phase (First Cycle):', 'description': 'Observational phase (first cycle):\n\nDay 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \\[5-HT3\\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).'}], 'classes': [{'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 21 days after cycle 1 of chemotherapy treatment', 'description': 'Complete response is defined as no vomiting and no use of rescue treatment within the first cycle of Docetaxel-Cyclophosphamide for the treatment of early-stage breast cancer patients. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '27 patients were excluded from the main analysis: 16 received docetaxel and cyclophosphamide (TC) at a different dose from that in the protocol, 9 had received previous emetogenic chemotherapy and 2 withdrew study consent before receiving TC.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Response (CR) in Cycle 2 for Patient Without Complete Response in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant NCR', 'description': 'Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):\n\nDay 0: dexamethasone oral (8 mg Day 1: iv/oral\\* 5-hydroxytryptamine 3 \\[5-HT3\\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to cycle 2, and average of 6 weeks', 'description': 'To evaluate in cycle 2 the efficacy of aprepitant (days 1, 2 and 3) as secondary prevention in patients without complete response in cycle 1. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 185 evaluable patients, 161 achieved CR, so who participated in this outcome were 24 patients who experienced non-complete response (NCR).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Related Adverse Events (AE) at Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant NCR', 'description': 'Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):\n\nDay 0: dexamethasone oral (8 mg Day 1: iv/oral\\* 5-hydroxytryptamine 3 \\[5-HT3\\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 2, and average of 3 weeks', 'description': 'Events are related to the primary end point, they were collected only in the diary during the period of diary data collection (Day 1 to the morning of Day 6) for the cycle 2, unless they meet the definition of a serious adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 185 evaluable patients, 161 achieved CR, so who participated in this outcome were 24 patients who experienced non-complete response (NCR).'}, {'type': 'SECONDARY', 'title': 'Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Observational phase (first cycle):\n\nDay 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \\[5-HT3\\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).\n\nPatients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):\n\nDay 0: dexamethasone oral (8 mg Day 1: iv/oral\\* 5-hydroxytryptamine 3 \\[5-HT3\\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg'}], 'classes': [{'title': 'Cycle 1 pre-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000', 'lowerLimit': '36.36', 'upperLimit': '51.05'}]}]}, {'title': 'Cycle 1 post-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.2', 'groupId': 'OG000', 'lowerLimit': '50.59', 'upperLimit': '67.75'}]}]}, {'title': 'Cycle 1 pre-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '39.99', 'upperLimit': '44.94'}]}]}, {'title': 'Cycle 1 post-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.22', 'groupId': 'OG000', 'lowerLimit': '42.04', 'upperLimit': '46.79'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of Chemotherapy-Induced Nausea and Vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and Vomiting on daily life. There are 18 items, each on a 7-point scale. Results are reported as a total score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea or vomiting (better outcome) (Maximum 126, Minimum 18).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'From 212 patients randomized, 27 were not evaluable patients. From the rest 185, 161 presented CR, and 24 a NCR.'}, {'type': 'SECONDARY', 'title': 'Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Observational phase (first cycle):\n\nDay 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \\[5-HT3\\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).\n\nPatients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):\n\nDay 0: dexamethasone oral (8 mg Day 1: iv/oral\\* 5-hydroxytryptamine 3 \\[5-HT3\\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg'}], 'classes': [{'title': 'Cycle 1 pre-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.85', 'groupId': 'OG000', 'lowerLimit': '16.23', 'upperLimit': '23.46'}]}]}, {'title': 'Cycle 1 post-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.73', 'groupId': 'OG000', 'lowerLimit': '26.56', 'upperLimit': '36.89'}]}]}, {'title': 'Cycle 1 pre-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.93', 'groupId': 'OG000', 'lowerLimit': '17.76', 'upperLimit': '20.10'}]}]}, {'title': 'Cycle 1 post-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.27', 'groupId': 'OG000', 'lowerLimit': '19.12', 'upperLimit': '21.42'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of nausea associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and vomiting on daily life. There are 9 nausea-related items, each on a 7-point scale. Results are reported as a nausea score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea (better outcome) (Maximum 63, Minimum 9).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'From 212 patients randomized, 27 were not evaluable patients. From the rest 185, 161 presented CR, and 24 a NCR.'}, {'type': 'SECONDARY', 'title': 'Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Observational phase (first cycle):\n\nDay 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \\[5-HT3\\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).\n\nPatients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):\n\nDay 0: dexamethasone oral (8 mg Day 1: iv/oral\\* 5-hydroxytryptamine 3 \\[5-HT3\\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg'}], 'classes': [{'title': 'Cycle 1 pre-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.86', 'groupId': 'OG000', 'lowerLimit': '19.84', 'upperLimit': '27.89'}]}]}, {'title': 'Cycle 1 post-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.46', 'groupId': 'OG000', 'lowerLimit': '22.01', 'upperLimit': '32.88'}]}]}, {'title': 'Cycle 1 pre-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.53', 'groupId': 'OG000', 'lowerLimit': '22.07', 'upperLimit': '25'}]}]}, {'title': 'Cycle 1 post-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.15', 'groupId': 'OG000', 'lowerLimit': '22.76', 'upperLimit': '25.54'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of vomiting on daily life. There are 9 vomiting-related items, each on a 7-point scale. Results are reported as a vomiting score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of vomiting (better outcome) (Maximum 63, Minimum 9).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'From 212 patients randomized, 27 were not evaluable patients. From the rest 185, 161 presented CR, and 24 a NCR.'}, {'type': 'SECONDARY', 'title': 'Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant NCR', 'description': 'Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):\n\nDay 0: dexamethasone oral (8 mg Day 1: iv/oral\\* 5-hydroxytryptamine 3 \\[5-HT3\\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg'}], 'classes': [{'title': 'Cycle 2 pre-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000', 'lowerLimit': '25.74', 'upperLimit': '49.86'}]}]}, {'title': 'Cycle 2 post-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.4', 'groupId': 'OG000', 'lowerLimit': '52.07', 'upperLimit': '76.64'}]}]}, {'title': 'Cycle 2 pre-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.28', 'groupId': 'OG000', 'lowerLimit': '30.20', 'upperLimit': '56.36'}]}]}, {'title': 'Cycle 2 post-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000', 'lowerLimit': '43.7', 'upperLimit': '51.75'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 6', 'description': 'To determine the total incidence of Chemotherapy-Induced Nausea and Vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and Vomiting on daily life. There are 18 items, each on a 7-point scale. Results are reported as a total score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea or vomiting (better outcome) (Maximum 126, Minimum 18).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'During cycle 2, only 23 patients completed the FLIE questionnaire.'}, {'type': 'SECONDARY', 'title': 'Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant NCR', 'description': 'Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):\n\nDay 0: dexamethasone oral (8 mg Day 1: iv/oral\\* 5-hydroxytryptamine 3 \\[5-HT3\\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg'}], 'classes': [{'title': 'Cycle 2 pre-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.71', 'groupId': 'OG000', 'lowerLimit': '11.07', 'upperLimit': '24.35'}]}]}, {'title': 'Cycle 2 post-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.16', 'groupId': 'OG000', 'lowerLimit': '28.26', 'upperLimit': '44.07'}]}]}, {'title': 'Cycle 2 pre-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.57', 'groupId': 'OG000', 'lowerLimit': '13.66', 'upperLimit': '25.48'}]}]}, {'title': 'Cycle 2 post-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.30', 'groupId': 'OG000', 'lowerLimit': '20.35', 'upperLimit': '28.25'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of Nausea associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Nausea on daily life. There are 9 items, each on a 7-point scale. Results are reported as a nausea score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea (better outcome) (Maximum 63, Minimum 9).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'During cycle 2, only 23 patients completed the FLIE questionnaire.'}, {'type': 'SECONDARY', 'title': 'Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant NCR', 'description': 'Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):\n\nDay 0: dexamethasone oral (8 mg Day 1: iv/oral\\* 5-hydroxytryptamine 3 \\[5-HT3\\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg'}], 'classes': [{'title': 'Cycle 2 pre-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.09', 'groupId': 'OG000', 'lowerLimit': '12.82', 'upperLimit': '27.36'}]}]}, {'title': 'Cycle 2 post-chemotherapy NCR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.19', 'groupId': 'OG000', 'lowerLimit': '21.91', 'upperLimit': '34.47'}]}]}, {'title': 'Cycle 2 pre-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.71', 'groupId': 'OG000', 'lowerLimit': '16.40', 'upperLimit': '31.02'}]}]}, {'title': 'Cycle 2 post-chemotherapy CR patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.43', 'groupId': 'OG000', 'lowerLimit': '17.55', 'upperLimit': '29.30'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of vomiting on daily life. There are 9 items, each on a 7-point scale. Results are reported as a vomiting score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of vomiting (better outcome) (Maximum 63, Minimum 9).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'During cycle 2, only 23 patients completed the FLIE questionnaire.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aprepitant', 'description': 'Observational phase (first cycle):\n\nDay 0: Dexamethasone 8mg Day 1: 5-HydroxyTryptamine 3 (5-HT3) antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg.\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3: Dexamethasone 16 mg.\n\nPatients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle):\n\nDay 0: dexamethasone oral (8 mg Day 1: iv/oral\\* 5-hydroxytryptamine 3 \\[5-HT3\\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg'}], 'periods': [{'title': 'Observational Phase (First Cycle)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'From these 185 completed patients, only 24 experiment emesis on Cycle 1 (NCR) (efficacy phase).', 'groupId': 'FG000', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Received TC at a different dose', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'previous emetogenic chemotherapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}, {'title': 'Efficacy Phase (Second Cycle)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The investigator registered all the selected patients before the start of the treatment.\n\nOnce it was verified that the selection criteria were complied with, the investigator sent the previously completed randomization sheet by fax to Spanish Breast Cancer Research Group (GEICAM).\n\nRecruitment period: From May-2011 to 31-Jan-13.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aprepitant', 'description': 'Observational phase (first cycle):\n\nDay 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg).\n\n• Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).\n\nEfficacy phase (second cycle):\n\nDay 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg).\n\nChemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg).\n\nAprepitant: Efficacy phase (second cycle)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '212', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Arab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) status', 'classes': [{'categories': [{'title': 'ECOG 0', 'measurements': [{'value': '185', 'groupId': 'BG000'}]}, {'title': 'ECOG 1', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG score runs from 0 to 5, with 0 denoting perfect health and 5 death. 0 - Asymptomatic\n\n1. \\- Symptomatic but completely ambulatory\n2. \\- Symptomatic, \\<50% in bed during the day\n3. \\- Symptomatic, \\>50% in bed, but not bedbound\n4. \\- Bedbound\n5. \\- Death', 'unitOfMeasure': 'Participants'}, {'title': 'Menopausal Status', 'classes': [{'categories': [{'title': 'Premenopausal', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Postmenopausal', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drink alcohol', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '168', 'groupId': 'BG000'}]}, {'title': 'Not available', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Regularly dizziness', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '176', 'groupId': 'BG000'}]}, {'title': 'Not available', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Morning nausea during pregnancy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '142', 'groupId': 'BG000'}]}, {'title': 'Not available', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'From May 2011 to March 2013, 212 Early Breast Cancer (EBC) patients from 12 sites in Spain were recruited.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients that experiment emesis within the first cycle in spite of the administration of antiemetics, may opt to participate in a subsequent efficacy phase'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2011-02-11', 'resultsFirstSubmitDate': '2019-01-08', 'studyFirstSubmitQcDate': '2011-02-15', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-02', 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Complete Response (CR)', 'timeFrame': 'Up to 21 days after cycle 1 of chemotherapy treatment', 'description': 'Complete response is defined as no vomiting and no use of rescue treatment within the first cycle of Docetaxel-Cyclophosphamide for the treatment of early-stage breast cancer patients. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Complete Response (CR) in Cycle 2 for Patient Without Complete Response in Cycle 1', 'timeFrame': 'Up to cycle 2, and average of 6 weeks', 'description': 'To evaluate in cycle 2 the efficacy of aprepitant (days 1, 2 and 3) as secondary prevention in patients without complete response in cycle 1. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.'}, {'measure': 'Number of Participants With Treatment Related Adverse Events (AE) at Cycle 2', 'timeFrame': 'Cycle 2, and average of 3 weeks', 'description': 'Events are related to the primary end point, they were collected only in the diary during the period of diary data collection (Day 1 to the morning of Day 6) for the cycle 2, unless they meet the definition of a serious adverse event.'}, {'measure': 'Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of Chemotherapy-Induced Nausea and Vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and Vomiting on daily life. There are 18 items, each on a 7-point scale. Results are reported as a total score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea or vomiting (better outcome) (Maximum 126, Minimum 18).'}, {'measure': 'Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of nausea associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and vomiting on daily life. There are 9 nausea-related items, each on a 7-point scale. Results are reported as a nausea score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea (better outcome) (Maximum 63, Minimum 9).'}, {'measure': 'Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of vomiting on daily life. There are 9 vomiting-related items, each on a 7-point scale. Results are reported as a vomiting score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of vomiting (better outcome) (Maximum 63, Minimum 9).'}, {'measure': 'Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2', 'timeFrame': 'Up to day 6', 'description': 'To determine the total incidence of Chemotherapy-Induced Nausea and Vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and Vomiting on daily life. There are 18 items, each on a 7-point scale. Results are reported as a total score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea or vomiting (better outcome) (Maximum 126, Minimum 18).'}, {'measure': 'Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of Nausea associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Nausea on daily life. There are 9 items, each on a 7-point scale. Results are reported as a nausea score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea (better outcome) (Maximum 63, Minimum 9).'}, {'measure': 'Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2', 'timeFrame': 'Up to day 6', 'description': 'To determine the incidence of vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR).\n\nThe FLIE questionnaire is a validated, patient-reported instrument to measure the impact of vomiting on daily life. There are 9 items, each on a 7-point scale. Results are reported as a vomiting score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of vomiting (better outcome) (Maximum 63, Minimum 9).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Early-stage breast cancer patients'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '26994459', 'type': 'RESULT', 'citation': 'Llombart-Cussac A, Ramos M, Dalmau E, Garcia-Saenz JA, Gonzalez-Farre X, Murillo L, Calvo L, Morales S, Caranana V, Gonzalez A, Fernandez-Morales LA, Moreno F, Casas MI, Angulo Mdel M, Camara MC, Garcia-Mace AI, Carrasco E, Jara-Sanchez C. Incidence of chemotherapy-induced nausea and vomiting associated with docetaxel and cyclophosphamide in early breast cancer patients and aprepitant efficacy as salvage therapy. Results from the Spanish Breast Cancer Group/2009-02 study. Eur J Cancer. 2016 May;58:122-9. doi: 10.1016/j.ejca.2016.01.015. Epub 2016 Mar 17.'}], 'seeAlsoLinks': [{'url': 'http://www.geicam.org/', 'label': "Sponsor's website"}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, open label, non-comparative trial in Spain.\n\nThe primary objective of this study is to determine the complete response, defined as no vomiting and no use of rescue treatment, in women with early-stage breast cancer treated with one cycle of Docetaxel-Cyclophosphamide and active therapy for the prevention of CINV (Chemotherapy-induced nausea and vomiting) day 1, 5-hydroxytryptamine 3 (5-HT3) antagonist plus 3 days of dexamethasone. A second step (efficacy phase) is designed to examine the efficacy and tolerability of aprepitant in the second cycle among patients who failed to the previous CINV prevention treatment.\n\nThe study will focus on early-stage chemonaive breast cancer patients receiving docetaxel-cyclophosphamide and a 5-HT3 antagonist plus dexamethasone for the CINV prevention. The CINV incidence in those patients will be evaluated on the first cycle. All refractory patients, will be asked to participate in the second phase, where aprepitant on days 1, 2 and 3 will be added to their antiemetic regimen.\n\nAssuming a drop out of 5%, 212 patients will be included in the study. It is anticipated that around 48 patients will enter the efficacy phase.\n\nThe duration of the study, from first patient visit to last patient visit will be approximately 21 months.', 'detailedDescription': "Sample size We want to obtain an estimation of the percent of the patients that we assume won't have a response to the treatment against vomiting. Reviewing bibliography, we think that the percent is approximately 25%.\n\nWe are going to obtain an estimation of this percent with an accuracy of +/- 6%, with a bilateral confidence level of 95% bilateral. Whit all this premises it would be needed 201 patients.\n\nAssuming a drop out of 5%, 212 patients will be included in the study.\n\nA maximum of 212 patients will be included in the trial. It is anticipated that around 48 patients will enter the efficacy phase.\n\nAPPROXIMATE DURATION OF THE STUDY. Inclusion period: 18 months approximately. Estimated follow-up: December 2012 Estimated date of end of study: June 2013"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patient ≥ 18 years of age.\n2. Patient has a histological confirmed early-stage (I to III) breast cancer.\n3. Patient is able to understand study procedures and agrees to participate in the study by giving written informed consent.\n4. Patient is naive to moderate or highly emetogenic chemotherapy per "Hesketh" criteria.\n5. Patient is scheduled to receive of chemotherapy with Docetaxel-Cyclophosphamide (Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2) administered every 21 days.\n6. Patient has a predicted life expectancy ≥ 4 months.\n7. Functional State 0-1 Eastern Cooperative Oncology Group (ECOG) Scale (see Appendix 12.2).\n8. Patient has an adequate organ function including the following:\n\n * Bone marrow reserve: Absolute Neutrophil Count \\>1500/mm3 and white blood cell (WBC) count \\>3000/mm3; Platelet Count \\>100.000/mm3\n * Hepatic: aspartate aminotransferase (AST) \\<2.5 x upper limit of normal; alanine aminotransferase (ALT) \\<2.5 x upper limit of normal; Bilirubin within the normal limit.\n * Renal: Creatinine \\<1.5 x upper limit of normal.\n9. Premenopausal female patients must demonstrate a negative serum and/or urine pregnancy test within 3 days of study drug administration, and agree to use a double-barrier form of contraception for at least 14 days prior to, throughout and for at least 14 days following the last dose of study medication. Women taking oral contraceptive agents must agree to add a barrier form of contraception. Abstinence is also considered an acceptable form of contraception. (Note: A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient who is not of reproductive potential is defined as one who has either: 1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea); 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or 3) bilateral tubal ligation.)\n10. Patient is able to read, understand and complete study questionnaires.\n\nExclusion Criteria:\n\n1. Patient is scheduled to receive any chemotherapy treatment different to the Docetaxel-Cyclophosphamide chemotherapy.\n2. Patient has received or will receive radiation therapy to the abdomen, chest or pelvis in the month prior to the study enter.\n3. Patient has vomited in the 24 hours prior to Treatment Day 1.\n4. Patient has a history of treatment with emetogenic chemotherapy of moderate or high level per "Hesketh" (classification of emetogenic chemotherapy agents).\n5. Patient has an active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.\n6. Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.\n7. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.\n8. Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.\n9. Patient has a history of hypersensitivity to aprepitant, 5-HT3 antagonists, or dexamethasone.\n10. Patient is pregnant or breast feeding.\n11. Patient has participated in a study with aprepitant or has taken a non approved (investigational) drug within the last 4 weeks.\n12. Patient is taking systemic corticosteroid therapy at any dose; topical and inhaled corticosteroids are permitted.\n13. Patient is taking, or will be taking within 28 days of Day 1 of cycle 2 (cycle in which patients will start taking aprepitant) the following CYP3A4 inducers:\n\n * phenytoin or carbamazepine\n * barbiturates\n * rifampicin or rifabutin\n * St. John\'s Wort\n14. Patient is taking, or will be taking within 7 days of Day 1 of cycle 2 the following CYP3A4 substrates:\n\n * terfenadine\n * cisapride\n * astemizole\n * pimozide\n15. Patient is taking, or will be taking within the 7 days of Day 1 of cycle 2 the following CYP3A4 inhibitors:\n\n * clarithromycin\n * ketoconazole, itraconazole\n16. Patient will be taking an antiemetic within 48 hours of Day 1 of cycle 2. Prohibited antiemetics include:\n\n * 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron or palonosetron)\n * phenothiazines (e.g., prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine)\n * butyrophenones (e.g., haloperidol or droperidol)\n * benzamides (e.g., metoclopramide or alizapride)\n * domperidone\n * cannabinoids\n * herbal therapies with potential antiemetic properties\n * scopolamine\n * cyclizine\n17. Patient has used benzodiazepines or opiates, except for single daily doses of triazolam, temazepam or midazolam in the 48 hours prior to Day 1 of cycle 2. Continuation of chronic benzodiazepines or opiate therapy is permitted provided it was initiated at least 48 hours before enrollment.'}, 'identificationModule': {'nctId': 'NCT01298193', 'briefTitle': 'Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Breast Cancer Research Group'}, 'officialTitle': 'A Prospective, Open Label, Non-comparative Trial to Determine the Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With the Docetaxel-Cyclophosphamide Regimen in Early Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'GEICAM/2009-02'}, 'secondaryIdInfos': [{'id': '2010-022689-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aprepitant', 'description': 'Observational phase (first cycle):\n\nDay 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg) + Chemotherapy (Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 ).\n\nDays 2 and 3 (Dexamethasone 16 mg).\n\nIf not complete response:\n\nEfficacy phase (second cycle):\n\nDay 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg)+ Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 .\n\nDays 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg).', 'interventionNames': ['Drug: Aprepitant']}], 'interventions': [{'name': 'Aprepitant', 'type': 'DRUG', 'otherNames': ['Rescue therapy:Patients may be provided with a prescription.', '- 5-HT3 antagonists', '- Phenothiazines.', '- Butyrophenones (e.g., haloperidol or droperidol)', '- Benzamides (e.g., metoclopramide or alizapride)', '- Benzodiazepines', '- Corticosteroids', '- Domperidone'], 'description': 'Efficacy phase (second cycle)', 'armGroupLabels': ['Aprepitant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporació Sanitaria Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '28805', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Príncipe de Asturias', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}, {'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Alcorcón', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'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': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', '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': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '25189', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Universitario Arnau de Vilanova de Lleida', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '27004', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Complejo Hospitalario Xeral-Calde', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Arnau de Vilanova de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Arnau de Vilanova'}, {'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundación Hospital Alcorcón'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Breast Cancer Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}