Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
NCT ID: NCT04540692
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
444 participants
INTERVENTIONAL
2021-01-12
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Start with Cyclophosphamide + Doxorrubicin
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.
Cyclophosphamide + Doxorrubicin
Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
Start with Docetaxel or Paclitaxel
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.
Docetaxel or Paclitaxel
Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks
Interventions
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Docetaxel or Paclitaxel
Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks
Cyclophosphamide + Doxorrubicin
Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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;
* The participant (or legally acceptable representative, if applicable) provides written informed consent for the study;
* 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;
* 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.
* Have adequate organic function. The samples must be collected within 60 days before the start of the study treatment;
* Have adequate cardiac function as assessed by echocardiogram or MUGA performed up to 60 days before the start of treatment under study.
18 Years
FEMALE
No
Sponsors
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Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
UNKNOWN
Latin American Cooperative Oncology Group
OTHER
Responsible Party
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Principal Investigators
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José Bines
Role: PRINCIPAL_INVESTIGATOR
Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
Locations
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Hospital Evangélico de Cachoeiro de Itapemirim - Centro de Pesquisas Clínicas em Oncologia (CPCO)
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Santa Casa de Misericórdia da Bahia - Hospital Santa Izabel
Salvador, Estado de Bahia, Brazil
Centro de Pesquisa do Hospital Araújo Jorge
Goiânia, Goiás, Brazil
ICTR - Instituto do Câncer e Transplante de Curitiba
Curitiba, Paraná, Brazil
HUEM/CEON - Hospital Universitário Evangélico Mackenzie
Curitiba, Paraná, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
IMIP - Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, Brazil
Hospital Universitário Oswaldo Cruz (UNIPECLIN)
Recife, Pernambuco, Brazil
HINJA - Hospital Jardim Amália
Volta Redonda, Rio de Janeiro, Brazil
HCPA - Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
CEPON - Centro de Pesquisas Oncológicas
Florianópolis, Santa Catarina, Brazil
Hospital de Amor de Barretos
Barretos, São Paulo, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista (UPECLIN)
Botucatu, São Paulo, Brazil
Faculdade de Ciências Médicas da Unicamp
Campinas, São Paulo, Brazil
Hospital de Amor Jales - Hospital de Câncer de Barretos
Jales, São Paulo, Brazil
INCA - Instituto Nacional de Câncer
Rio de Janeiro, , Brazil
ICESP - Instituto do Câncer do Estado de São Paulo
São Paulo, , Brazil
IBCC Oncologia - Núcleo de Pesquisa São Camilo
São Paulo, , Brazil
Countries
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Central Contacts
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Other Identifiers
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LACOG 0419
Identifier Type: OTHER
Identifier Source: secondary_id
GBECAM 0419
Identifier Type: -
Identifier Source: org_study_id
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