Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT05599334
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2022-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeanne.suissa@pierre-fabre.com', 'phone': '+33149108269', 'title': 'Medical Director (Jeanne Suissa)', 'organization': 'Pierre Fabre Médicament'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the baseline to the study entry date', 'eventGroups': [{'id': 'EG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 10, 'seriousNumAtRisk': 108, 'deathsNumAffected': 1, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Decreased apetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Enterovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hyperhydrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Muscle spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nasal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Skin disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Skin fissures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Strabismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vulvovaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'seriousEvents': [{'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Infected seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hepatic enzymze increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Description of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'spread': '8.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Age will be assessed in years = neratinib initiation date - date of birth', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Description of Gender', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'male', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Gender will be described in percentage of Male and Female among patients', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Description of BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'spread': '5.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'BMI will be assessed in kg/m2', 'unitOfMeasure': 'Kg/m²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Menopausal Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'title': 'premenopausal', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'perimenopausal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'postmenopausal', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'surgical/other reason for amenorrhea', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'unavailable', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Not applicable (Male)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline', 'description': 'Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Comorbidities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity. Comorbidities were including but were not limited to: renal disease, liver disease, gastro-intestinal disorders, cardiovascular conditions, skin and subcutaneous disorders, diabetes (type I or II)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'HER2 Overexpression/Amplification Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'title': 'IHC 3+ (positive)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'IHC 2+ (equivocal)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'IHC no', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At initial diagnosis', 'description': 'HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Hormone Receptor Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'title': 'Estrogen receptor (ER) positive', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'ER negative', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'progesterone receptor (PR) positive', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'PR negative', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At initial diagnosis', 'description': 'Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Primary Tumor Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'title': 'Left breast', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Right breast', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At initial diagnosis', 'description': 'Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Primary Tumor Histology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'title': 'Infiltrating ductal carcinoma', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Infiltrating lobular carcinoma', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Invasive carcinoma', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At initial diagnosis', 'description': 'Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Histological Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'title': 'G1 Well differentiated', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'G2 Moderately differentiated', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'G3 Poorly differentiated', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Unavailable', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At initial diagnosis', 'description': 'Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Pathologic Stage (AJCC Classification) of Breast Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'IIA', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'IIB', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'IIIA', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'IIIB', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'IIIC', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At initial diagnosis', 'description': 'Higher is the stage worse is the cancer.\n\nStage is defined as:\n\n1A: tumor (T) up to 2 cm + not spread outside the breast; no lymph nodes (LN).1B: Small clusters of cancer cells (CC) (0.2-2 mm) are found in LN, or T in the breast is \\< 2 cm and small clusters of CC are found in LN. 2A: No T in the breast, but cancer is in 1-3 axillary LN or in LN near the breastbone or T is 2 cm or smaller + has spread to 1-3 axillary LN or LN near the breastbone, or T is \\> 2 cm and \\< 5 cm and not spread to LN.2B: T is \\> 2 cm and \\< 5 cm and has spread to 1-3 axillary LN or LN near the breastbone, or T is \\> 5 cm and not spread to the LN. 3A: no T in the breast or the T is any size; cancer is found in 4-9 axillary LN or LN near the breastbone, or T is larger than 5 cm and small clusters of CC found in LN. 3B: T has spread to chest wall or breast skin + may have spread to up to 9 axillary LN. 3C: Cancer has spread to ≥10 axillary LN, LN near the collarbone, or LN near breastbone', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Belgium, Croatia, France, Italy and Spain between 01 August 2017 and 31 December 2020 (the patient identification period).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Neratinib Arm', 'description': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49.2', 'spread': '8.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '111 in the number of enrolled patients and 108 is the number of analysed patients in the FAS'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '107', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '111 in the number of enrolled patients and 108 is the number of analysed patients'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'The details of participants by ethnicity was not collected'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Croatia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The number of enrolled participants is 111 for which the region has been analysed. of note, the region has not been analysed in the 108 analysed participants from the FAS.', 'unitOfMeasure': 'participants', 'populationDescription': 'The total number of participants of participants is 111 corresponding to the enrolled number of participants on which the disposition by country was analysed, as this was not analysed in the 108 patients corresponding to the FAS. Therefore, the distribution by region has been done out of 111 patients, and not out of 108 patients.'}], 'populationDescription': 'The baseline characteristics have been analysed in 108 patients corresponding to the number of patients analysed in the Full Analysis Set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-22', 'size': 511757, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-10T05:12', 'hasProtocol': True}, {'date': '2023-09-22', 'size': 723941, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-10T05:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2022-02-10', 'resultsFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2022-10-25', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-12', 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of Age', 'timeFrame': 'At baseline', 'description': 'Age will be assessed in years = neratinib initiation date - date of birth'}, {'measure': 'Description of Gender', 'timeFrame': 'At baseline', 'description': 'Gender will be described in percentage of Male and Female among patients'}, {'measure': 'Description of BMI', 'timeFrame': 'At baseline', 'description': 'BMI will be assessed in kg/m2'}, {'measure': 'Menopausal Status', 'timeFrame': 'At baseline', 'description': 'Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea'}, {'measure': 'Comorbidities', 'timeFrame': 'At baseline', 'description': 'Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity. Comorbidities were including but were not limited to: renal disease, liver disease, gastro-intestinal disorders, cardiovascular conditions, skin and subcutaneous disorders, diabetes (type I or II)'}, {'measure': 'HER2 Overexpression/Amplification Testing', 'timeFrame': 'At initial diagnosis', 'description': 'HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)'}, {'measure': 'Hormone Receptor Status', 'timeFrame': 'At initial diagnosis', 'description': 'Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative'}, {'measure': 'Primary Tumor Location', 'timeFrame': 'At initial diagnosis', 'description': 'Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer'}, {'measure': 'Primary Tumor Histology', 'timeFrame': 'At initial diagnosis', 'description': 'Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other'}, {'measure': 'Histological Grade', 'timeFrame': 'At initial diagnosis', 'description': 'Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated'}, {'measure': 'Pathologic Stage (AJCC Classification) of Breast Cancer', 'timeFrame': 'At initial diagnosis', 'description': 'Higher is the stage worse is the cancer.\n\nStage is defined as:\n\n1A: tumor (T) up to 2 cm + not spread outside the breast; no lymph nodes (LN).1B: Small clusters of cancer cells (CC) (0.2-2 mm) are found in LN, or T in the breast is \\< 2 cm and small clusters of CC are found in LN. 2A: No T in the breast, but cancer is in 1-3 axillary LN or in LN near the breastbone or T is 2 cm or smaller + has spread to 1-3 axillary LN or LN near the breastbone, or T is \\> 2 cm and \\< 5 cm and not spread to LN.2B: T is \\> 2 cm and \\< 5 cm and has spread to 1-3 axillary LN or LN near the breastbone, or T is \\> 5 cm and not spread to the LN. 3A: no T in the breast or the T is any size; cancer is found in 4-9 axillary LN or LN near the breastbone, or T is larger than 5 cm and small clusters of CC found in LN. 3B: T has spread to chest wall or breast skin + may have spread to up to 9 axillary LN. 3C: Cancer has spread to ≥10 axillary LN, LN near the collarbone, or LN near breastbone'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2-positive Breast Cancer', 'Adjuvant therapy'], 'conditions': ['Breast Cancer', 'Adjuvant Therapy', 'HER2-positive Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '41160302', 'type': 'DERIVED', 'citation': 'Krizic M, Silovski T, Hoste G, Dedic Plavetic N, Romano O, Gonzalez Farre X, Cano Jimenez A, Guerrero Zotano A, Suissa J, Beghdad F, Dialla O, Zivanov M, De Laurentiis M. A Retrospective Observational Study of Extended Adjuvant Neratinib for HER2-Positive Early-Stage Breast Cancer in a European Early Access Program. Oncol Ther. 2025 Dec;13(4):1205-1224. doi: 10.1007/s40487-025-00392-w. Epub 2025 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the demographic and clinical profiles of patients with early-stage HER2+ breast cancer treated with neratinib as an extended adjuvant therapy as part of the Early Access Program (EAP) in Europe.', 'detailedDescription': 'Eligible patients were selected among those who had received at least one dose of neratinib in the context of the early access program conducted in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP. Patients were followed up until the end of the study observation period/study entry date (05 July 2022). As this study was retrospective, the decision to prescribe neratinib was taken prior to and independent of the proposal to select a patient for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include all patients with early-stage HER2+ breast cancer having received at least one dose of neratinib as an extended adjuvant therapy in the context of the EAP in Europe between August 01, 2017 and December 31, 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be eligible for inclusion if they fulfill all of the following criteria:\n\n * Age ≥ 18 years at neratinib treatment initiation\n * Having received at least one initial dose of neratinib as an extended adjuvant therapy for the treatment of early-stage HER2+ breast cancer, in the context of the EAP in Europe, and between August 01, 2017 and December 31, 2020\n * Patients (or next of kin/legal representative, if applicable) who provide written informed consent or non-opposition.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05599334', 'acronym': 'NEAR', 'briefTitle': 'A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'A Retrospective Observational Study of Adult Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib as Extended Adjuvant Therapy in the Context of the European Early Access Program (NEAR)', 'orgStudyIdInfo': {'id': 'NIS12501'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bouge', 'country': 'Belgium', 'facility': 'Clinique Saint-Luc Bouge', 'geoPoint': {'lat': 50.47193, 'lon': 4.89218}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis - Campus Virga Jesse', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Multidisciplinary Breast Unit of the University Hospital Leuven and Sint-Andries Hospital', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Center Zagreb, Department of Oncology, Breast Unit', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHU Brest - Hôpital Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Lille', 'country': 'France', 'facility': 'Centre Bourgogne', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hopital Prive La Louviere', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Arezzo', 'country': 'Italy', 'facility': 'Ospedale San Donato- ASL 8 Arezzo', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'city': 'Fano', 'country': 'Italy', 'facility': 'Ospedale Santa Croce', 'geoPoint': {'lat': 43.84052, 'lon': 13.01665}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori Fondazione G. Pascale, Dipartimento di Senologia Via Mariano Semmola', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Parma', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Quironsalud Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Teknon Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Jaén', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'city': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Universitari Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ruber Internacional', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Sant Cugat del Vallès', 'country': 'Spain', 'facility': 'Hospital General de Catalunya', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}, {'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Oncología IVO, Servicio de Oncología Médica C/ Beltran Baguena', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital LLuís Alcanyís de Xàtiva', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Jeanne Suissa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pierre Fabre Médicament'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Iqvia Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}