Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
Study NCT ID:
NCT04540692
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2020-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 444}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Invasive disease-free survival (IDFS)', 'timeFrame': 'An average of 8 years', 'description': 'Defined as the time elapsed between the date of randomization and the date of invasive recurrence (excludes carcinoma in situ) or death, whichever comes first..'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.', 'detailedDescription': "Multicenter, phase III, open-label, randomized clinical trial, which will include 494 patients randomized to two neoadjuvant chemotherapy arms. The treatment protocol will be the same in both groups, only the regimens sequences will be evaluated: starting with anthracycline versus taxane, with or without carboplatin for patients with triple negative subtype. The chemotherapy regimen will follow the institution's routine, which includes the use of CA in the anthracyclical phase and, in the taxane phase, the use of docetaxel every 21 days or weekly paclitaxel. The rest of the treatment (surgery, radiotherapy, hormone therapy) will not be part of the study and will be carried out according to institutional guidelines."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participants, with at least 18 years old on the day of signing the free and informed consent;\n* Invasive breast carcinoma stage III (RH positive) or IIB/III (RH negative), according to TNM 8th edition; Histologically confirmed diagnosis of invasive breast carcinoma (with any histology), HER-2 negative;\n* The participant (or legally acceptable representative, if applicable) provides written informed consent for the study;\n* The participant must agree to use a contraceptive as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of the study treatment;\n* Have a functional capacity according to the Eastern Cooperative Oncology Group (ECOG) from 0 to 2. The evaluation of the ECOG must be carried out within 7 days before the inclusion date.\n* Have adequate organic function. The samples must be collected within 60 days before the start of the study treatment;\n* Have adequate cardiac function as assessed by echocardiogram or MUGA performed up to 60 days before the start of treatment under study.\n\nExclusion Criteria:\n\n\\- Individuals who do not meet the inclusion criteria above-mentioned.'}, 'identificationModule': {'nctId': 'NCT04540692', 'acronym': 'NEOSAMBA', 'briefTitle': 'Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Latin American Cooperative Oncology Group'}, 'officialTitle': 'NEOSAMBA Clinical Trial - Stage I', 'orgStudyIdInfo': {'id': 'GBECAM 0419'}, 'secondaryIdInfos': [{'id': 'LACOG 0419', 'type': 'OTHER', 'domain': 'LACOG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Start with Cyclophosphamide + Doxorrubicin', 'description': 'Patients will receive the following treatment schedule: Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles, followed by docetaxel 75-100mg/m2 intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m2 for 12 weeks.', 'interventionNames': ['Drug: Cyclophosphamide + Doxorrubicin']}, {'type': 'EXPERIMENTAL', 'label': 'Start with Docetaxel or Paclitaxel', 'description': 'Patients will receive the following treatment schedule: Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks, followed by Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days, for 3 cycles.', 'interventionNames': ['Drug: Docetaxel or Paclitaxel']}], 'interventions': [{'name': 'Docetaxel or Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxotere or Taxol'], 'description': 'Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks', 'armGroupLabels': ['Start with Docetaxel or Paclitaxel']}, {'name': 'Cyclophosphamide + Doxorrubicin', 'type': 'DRUG', 'otherNames': ['Citoxan + Rubidox'], 'description': 'Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles', 'armGroupLabels': ['Start with Cyclophosphamide + Doxorrubicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29.308-065', 'city': 'Cachoeiro de Itapemirim', 'state': 'Espírito Santo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Sabina Bandeira Aleixo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)', 'geoPoint': {'lat': -20.84889, 'lon': -41.11278}}, {'zip': '400.50-410', 'city': 'Salvador', 'state': 'Estado de Bahia', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Daniela Galvão Barros de Oliveira', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '74.605-010', 'city': 'Goiânia', 'state': 'Goiás', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Geraldo Silva Queiroz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Pesquisa do Hospital Araújo Jorge', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '80.510-130', 'city': 'Curitiba', 'state': 'Paraná', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Gisah Guilgen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ICTR - Instituto do Câncer e Transplante de Curitiba', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '80.730-150', 'city': 'Curitiba', 'state': 'Paraná', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Maria Cristina Figueroa Magalhães', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HUEM/CEON - Hospital Universitário Evangélico Mackenzie', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '81.520-060', 'city': 'Curitiba', 'state': 'Paraná', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'João Soares Nunes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Erasto Gaertner', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '50.070-902', 'city': 'Recife', 'state': 'Pernambuco', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Andréa Lopes Ponte de Souza', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IMIP - Instituto de Medicina Integral Professor Fernando Figueira', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '50.110-130', 'city': 'Recife', 'state': 'Pernambuco', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Thiago Lourenço Apolinário', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitário Oswaldo Cruz (UNIPECLIN)', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '27.251-260', 'city': 'Volta Redonda', 'state': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Heloísa Magda Resende', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HINJA - Hospital Jardim Amália', 'geoPoint': {'lat': -22.52306, 'lon': -44.10417}}, {'zip': '90.035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Pedro Emanuel Rubini Liedke', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HCPA - Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '88.034-000', 'city': 'Florianópolis', 'state': 'Santa Catarina', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Yeni Verônica Nerón', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CEPON - Centro de Pesquisas Oncológicas', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'zip': '14.784-400', 'city': 'Barretos', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Cristiano de Pádua Souza', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Amor de Barretos', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '18.618-686', 'city': 'Botucatu', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Ana Lucia Coradazzi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '13.083-881', 'city': 'Campinas', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Susana Oliveira Botelho Ramalho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculdade de Ciências Médicas da Unicamp', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '15.706-396', 'city': 'Jales', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Túlio Samara Rodrigues de Almeida Lucas Furquim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Amor Jales - Hospital de Câncer de Barretos', 'geoPoint': {'lat': -20.26889, 'lon': -50.54583}}, {'zip': '20.230-130', 'city': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Rodrigo Moura Araújo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'INCA - Instituto Nacional de Câncer', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01.246-000', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Laura Testa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ICESP - Instituto do Câncer do Estado de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04.014-002', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Lilian Arruda do Rêgo Barros', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IBCC Oncologia - Núcleo de Pesquisa São Camilo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Diana Rostirolla', 'role': 'CONTACT', 'email': 'diana.rostirolla@lacogcancerresearch.org', 'phone': '+55 51 3384 5334'}, {'name': 'Laura Voelcker', 'role': 'CONTACT', 'email': 'laura.voelcker@lacogcancerresearch.org', 'phone': '+55 51 3384-5334'}], 'overallOfficials': [{'name': 'José Bines', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Latin American Cooperative Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}