Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-04 @ 7:56 AM
Study NCT ID:
NCT04158258
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Costa Rica', 'Ecuador']}, '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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D000080044', 'term': 'Ado-Trastuzumab Emtansine'}, {'id': 'C485206', 'term': 'pertuzumab'}, {'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008453', 'term': 'Maytansine'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2907}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2019-11-05', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with Different Breast Cancer Subtypes at Diagnosis in Latin America', 'timeFrame': 'Baseline up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with Pathological Complete Response (pCR defined ypT0/is, N0)', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with Locoregional Recurrence (LRR)', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with Event Free Survival (EFS)', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with Invasive Disease-Free Survival (iDFS)', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with Overall Survival', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with Objective Response Rate (ORR)', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with Anti-Cancer Treatment Modifications', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with Breast Cancer Treatment based on Different Socio-Demographics Characteristics', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants (During Observation Period) with Pregnancy', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants (during Observation Period) with Pregnancy Outcomes', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with Non-Serious Adverse Events of Special Interests', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with AEs Leading to Discontinuation or Dose Modification', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants with Cardiac Safety Events', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Participants Adherent to Predefined Clinical Guideliens Regarding Anti-Cancer Treatment Regimens', 'timeFrame': 'Baseline up to approximately 6 years'}, {'measure': 'Percentage of Partcipants with Access to Biomarker Testing and Diagnostic Methods', 'timeFrame': 'Baseline up to approximately 6 years'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'A Prospective, Multicenter, Non-Interventional Study of Primary Data Collection, Designed to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcomes in Patients with Breast Cancer in Latin America.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients will be recruited from approximately 10 countries and from a variety of healthcare sites (ex: specialty care, private practice, teaching institution, etc.)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmed newly diagnosed stage I to IV (recurrent or de novo) breast cancer no more than 12 months prior to site activation, although they can have received anti-cancer treatment during that time\n\nExclusion Criteria:\n\n* Patients not receiving treatment for breast cancer with national approved drugs according to standard of care and in line with the current summary of product characteristics (SPC) /local labeling\n* Patients not receiving the Roche studied medicinal product, but a biosimilar'}, 'identificationModule': {'nctId': 'NCT04158258', 'briefTitle': 'A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A STUDY TO OBSERVE PATIENTS CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH NEWLY DIAGNOSED BREAST CANCER IN LATIN AMERICA', 'orgStudyIdInfo': {'id': 'MO39485'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bevacizumab', 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'interventionNames': ['Drug: Bevacizumab']}, {'label': 'Trastuzumab', 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'interventionNames': ['Drug: Trastuzumab']}, {'label': 'Ado-trastuzumab emtamsine', 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'interventionNames': ['Drug: Ado-trastuzumab emtamsine']}, {'label': 'Pertuzumab', 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'interventionNames': ['Drug: Pertuzumab']}, {'label': 'Atezolizumab', 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'interventionNames': ['Drug: Atezolizumab']}, {'label': 'Capecitabine', 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'interventionNames': ['Drug: Capecitabine']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'armGroupLabels': ['Bevacizumab']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'armGroupLabels': ['Trastuzumab']}, {'name': 'Ado-trastuzumab emtamsine', 'type': 'DRUG', 'otherNames': ['Kadcyla'], 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'armGroupLabels': ['Ado-trastuzumab emtamsine']}, {'name': 'Pertuzumab', 'type': 'DRUG', 'otherNames': ['Perjeta'], 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'armGroupLabels': ['Pertuzumab']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['Tecentriq'], 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'armGroupLabels': ['Atezolizumab']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Dosing and treatment duration of any studied medicinal products collected are at the discretion of the physician in accordance with local clinical practice and local labeling.', 'armGroupLabels': ['Capecitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1426', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto Alexander Fleming', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5000', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Instituto Oncologico De Cordoba', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '5016', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital Privado Centro Medico de Cordoba', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Morón', 'country': 'Argentina', 'facility': 'Hospital de Morón', 'geoPoint': {'lat': -34.65118, 'lon': -58.62205}}, {'zip': 'S2000KZE', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'Instituto de Oncología de Rosario', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'S2000ORE', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'Sanatorio de la Mujer', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '60336-550', 'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Crio - Centro Regional Integrado de Oncologia', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'zip': '86015-520', 'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital do Câncer de Londrina', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}, {'zip': '27251-260', 'city': 'Volta Redonda', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Jardim Amália', 'geoPoint': {'lat': -22.52306, 'lon': -44.10417}}, {'zip': '95020-450', 'city': 'Caxias do Sul', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Inst. de Vita', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}, {'zip': '90840-440', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Centro de Pesquisa em Oncologia', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '20560-120', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto Nacional de Cancer - INCa', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '03102-002', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Brasileiro De Controle Do Câncer - IBCC', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '7591046', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Clinica Las Condes', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8380000', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Instituto Nacional del Cancer', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '4781151', 'city': 'Temuco', 'country': 'Chile', 'facility': 'Hospital Dr. Hernan Henriquez Aravena', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'city': 'Barranquilla', 'country': 'Colombia', 'facility': 'Organización Clínica Bonnadona Prevenir S.A.S', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Inst. Nacional de Cancerologia', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'Centro Medico Imbanaco', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Floridablanca', 'country': 'Colombia', 'facility': 'Fundacion Cardiovascular de Colombia - Instituto del Corazón', 'geoPoint': {'lat': 7.06222, 'lon': -73.08644}}, {'zip': '10300', 'city': 'La Habana', 'country': 'Cuba', 'facility': 'Hospital Hermanos Ameijeiras', 'geoPoint': {'lat': 21.48412, 'lon': -77.67073}}, {'zip': '10150', 'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Instituto de Oncologia Dr. Heriberto Pieter', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'zip': '01015', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Grupo Angeles', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico CITY (federal District)', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cancerologia', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Zambrano Hellion TecSalud', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '50180', 'city': 'Toluca', 'country': 'Mexico', 'facility': 'Centro Oncologico Estatal ISSEMYM', 'geoPoint': {'lat': 19.28786, 'lon': -99.65324}}, {'zip': '15038', 'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto Nacional de Enfermedades Neoplasicas', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 41', 'city': 'Lima', 'country': 'Peru', 'facility': 'Clinica Internacional, Sede San Borja', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Aliada Centro Oncologico', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Montevideo', 'country': 'Uruguay', 'facility': 'Sanatorio CASMU', 'geoPoint': {'lat': -34.90328, 'lon': -56.18816}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Latin American Cooperative Oncology Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}