Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-02 @ 1:11 AM
Study NCT ID:
NCT05034393
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2021-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-09-02', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of type of first-line treatment', 'timeFrame': 'from January 2018 to December 2020'}], 'secondaryOutcomes': [{'measure': 'The PFS, defined as time from treatment start until progression (by image or physical exam) or death', 'timeFrame': 'from January 2018 to December 2020'}, {'measure': 'First-line treatment according to the drug name by type of health care coverage (public vs private)', 'timeFrame': 'from January 2018 to December 2020'}, {'measure': 'The PFS will be evaluated by type of health care coverage (public vs private).', 'timeFrame': 'from January 2018 to December 2020'}, {'measure': 'Timeline from first symptom to diagnosis', 'timeFrame': 'from January 2018 to December 2020'}, {'measure': 'Timeline from diagnosis to molecular test', 'timeFrame': 'from January 2018 to December 2020'}, {'measure': 'Timeline from diagnosis to the beginning of treatment', 'timeFrame': 'from January 2018 to December 2020'}, {'measure': "Patients' socioeconomic characteristics", 'timeFrame': 'from January 2018 to December 2020'}, {'measure': "Patients' demographics characteristics", 'timeFrame': 'from January 2018 to December 2020'}, {'measure': 'BC pathological characterization', 'timeFrame': 'from January 2018 to December 2020'}, {'measure': 'Rate of diagnostic tests to define breast cancer molecular subtypes performed', 'timeFrame': 'from January 2018 to December 2020'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to describe in detail the patient journey from diagnosis to the beginning of treatment and patterns of care of hormone receptor- positive, HER2-negative de novo or recurrent metastatic breast cancer between January 2018 and December 2020 in Brazil.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be performed in up to 15 sites in Brazil so that the recruitment target is reached within defined milestones. An adequate geographical distribution of sites within Brazil will be pursued to strengthen representation of Brazilian population. Considering the incidence of mBC.', 'genderDescription': 'Women histologically confirmed hormone receptor-positive HER2-negative invasive breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ≥18 years old\n* Histologically confirmed hormone receptor-positive HER2-negative invasive breast cancer\n* Hormone receptor-positive defined as 1% to 100% of tumor nuclei positive for Estrogen - - Receptor and/or Progesterone Receptor, as per ASCO/CAP Guideline 2020 - or Allred score of ≥3\n* HER2-negative defined as IHC result is 0/1+ or 2+ with ISH negative as per ASCO/CAP Guideline 2018\n* Diagnosed with de novo or recurrent metastatic breast cancer between January 2018 -and December 2020\n* Public health system or private health system\n\nExclusion Criteria:\n\n* Male Breast Cancer\n* First-line treatment for mBC received through clinical trial'}, 'identificationModule': {'nctId': 'NCT05034393', 'acronym': 'BRAVE', 'briefTitle': 'Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil', 'organization': {'class': 'OTHER', 'fullName': 'Latin American Cooperative Oncology Group'}, 'officialTitle': 'Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil', 'orgStudyIdInfo': {'id': 'LACOG 0221'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with de novo or recurrent HR-positive HER2-negative mBC', 'description': 'Patients diagnosed with de novo or recurrent HR-positive HER2-negative mBC from January 2018 to December 2020'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69.020-030', 'city': 'Manaus', 'state': 'Amazonas', 'country': 'Brazil', 'facility': 'CINPAM - Centro Integrado de Pesquisa da Amazônia', 'geoPoint': {'lat': -3.10194, 'lon': -60.025}}, {'zip': '60.335-480', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'CRIO - Centro Regional Integrado de Oncologia', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '40.170-014', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'CLION - Clínica de Oncologia (Oncoclínicas)', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '70.200-730', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital Sírio-Libanês DF', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '70.335-900', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'IGESDF - Instituto de Gestão Estratégica em Saúde do Distrito Federal', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '79.332-020', 'city': 'Corumbá', 'state': 'Mato Grosso do Sul', 'country': 'Brazil', 'facility': 'Instituto do Câncer Brasil - Unidade Pantanal', 'geoPoint': {'lat': -19.00917, 'lon': -57.65333}}, {'zip': '79.601-001', 'city': 'Três Lagoas', 'state': 'Mato Grosso do Sul', 'country': 'Brazil', 'facility': 'Instituto do Câncer Brasil - Unidade Três Lagoas', 'geoPoint': {'lat': -20.78765, 'lon': -51.70338}}, {'zip': '82.520-040', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Instituto de Hematologia e Oncologia Curitiba (Oncoclínicas)', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '58.030-080', 'city': 'João Pessoa', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'CPO - Centro Paraibano de Oncologia (Oncoclínicas)', 'geoPoint': {'lat': -7.115, 'lon': -34.86306}}, {'zip': '27.251-260', 'city': 'Volta Redonda', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'HINJA - Hospital Jardim Armália', 'geoPoint': {'lat': -22.52306, 'lon': -44.10417}}, {'zip': '95.020-450', 'city': 'Caxias do Sul', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'CEPESG - Centro de Pesquisa e Educação da Serra Gaúcha', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}, {'zip': '90.035-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'HMV - Hospital Moinhos de Vento', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '16.901-100', 'city': 'Andradina', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Câncer Brasil - Unidade Andradina', 'geoPoint': {'lat': -20.89611, 'lon': -51.37944}}, {'zip': '20.230-130', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'INCA - Instituto Nacional de Câncer', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Gustavo Werutsky', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Latin American Cooperative Oncology Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Latin American Cooperative Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brazilian Breast Cancer Study Group (GBECAM)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}