Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT04247035
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2020-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Τreatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the outcome per treatment line', 'timeFrame': '5 years', 'description': 'To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': '• To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece', 'detailedDescription': '* To capture the treatment patterns and clinical characteristics of patients with ER/PR positive, HER2-negative MBC in Greece\n* To evaluate the outcome of patients per treatment line (objective response, progression free survival, time to disease progression per line of therapy), overall survival\n* To record adverse events per line of therapy\n* To recording of the causes of treatment discontinuation per line of therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with histological confirmed ER/PR positive, HER2-negative MBC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with histological confirmed ER/PR positive, HER2-negative MBC\n* Age \\>18 years old\n* Patients initiating first or second line therapy for ER/PR positive, HER2-negative MBC\n* Adequate hematologic, renal and hepatic function\n* Signed informed consent (ICF)\n\nExclusion Criteria:\n\n* Active malignancy other than MBC\n* Active infection'}, 'identificationModule': {'nctId': 'NCT04247035', 'acronym': 'MBC', 'briefTitle': 'Τreatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Society of Medical Oncology'}, 'officialTitle': 'Non-Interventional, Multi-center Registry of Recording of Treatment Standards and Outcomes of Patients With ER/PR Positive, HER2-negative Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'Metastatic Breast Cancer'}}, 'contactsLocationsModule': {'locations': [{'zip': '11475', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Kalliopi Sarikaki, SC', 'role': 'CONTACT', 'email': 'psarikaki@hesmo.gr', 'phone': '+302106457971'}], 'facility': 'Hellenic Society of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Sofia Agelaki, prof', 'role': 'CONTACT', 'email': 'agelakisofia@gmail.com', 'phone': '+302106457971'}, {'name': 'Kalliopi Sarikaki', 'role': 'CONTACT', 'email': 'psarikaki@hesmo.gr', 'phone': '+302106457971'}], 'overallOfficials': [{'name': 'Ioannis Boukovinas, Dr /Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HeSMO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Society of Medical Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}