Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III
- Conditions
- Breast Cancer
- Registration Number
- NCT02663973
- Lead Sponsor
- Latin American Cooperative Oncology Group
- Brief Summary
The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population
- Detailed Description
The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population. Other specific goals are:
* To evaluate the demographic and socio-demographic profile, comorbidities and reproductive risks, anthropometric profile and family history.
* Characterize the breast tumors immunophenotype through anatomopathological data, such as: tumor grade, estrogen receptor, progesterone receptor, HER2, Ki67.
* Describe the screening tests, main symptoms and cancer stage in the moment of the diagnosis.
* Describe the initial cancer treatment and locally advanced such as surgery, radiotherapy, chemotherapy and endocrine therapy.
* Describe palliative treatment for recurrent or metastatic breast cancer: chemotherapy, radiotherapy, biphosphonate, and others.
* Evaluate the clinical outcomes such as: local or diffuse relapse, period of time until progression to metastatic cancer, global lifespan and specific breast cancer lifespan.
* Evaluate clinical complications of the metastatic disease, such as: brain metastasis, spinal cord compression, skeletal related events.
* Analyze the demographical and socio-economical characteristics, clinical-pathological characteristics of the tumor, treatment, clinical outcomes, type of institution (private/public), and other factors that may impact clinical outcome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3000
- Woman ≥ 18 years old
- Invasive breast cancer stage I to IV proven by histology or cytology
- Patients with new pathological diagnosis of invasive primary BC after the site activation date
- Pathological diagnosis of invasive breast cancer during recruitment (6 months before center activation or until 3000 patients included)
- New primary cancer on the same breast or contralateral breast.
- Patient's medical chart is available and adequate for data collection
- Patient properly signed the informed consent form
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Description of the epidemiology of breast cancer in the Brazilian population Annually, during 5 years
- Secondary Outcome Measures
Name Time Method Characterization of the immunophenotypic markers of the tumor Annually, during 5 years estrogen receptor, progesterone receptor, HER2, Ki67
Initial treatment for breast cancer of Brazilian patients Annually, during 5 years Main symptoms presented by patients with breast cancer in Brazil Annually, during 5 years Type of palliative treatment for metastasis or recurrent breast cancer in Brazilian patients Annually, during 5 years Types of clinical complications displayed by breast cancer Brazilian patients Annually, during 5 years Description of the socioeconomical characteristics of the Brazilian population with breast cancer Annually, during 5 years Classification of breast cancer staging Annually, during 5 years Description of screening tests of breast cancer patients in Brazil Annually, during 5 years Clinical outcome of Brazilian breast cancer patients Annually, during 5 years Characterization of exterior factors that may impact clinical outcome of breast cancer Brazilian patients Annually, during 5 years
Trial Locations
- Locations (24)
Hospital AC Camargo
🇧🇷São Paulo, Brazil
Centro de Pesquisas da Serra Gaúcha
🇧🇷Caxias do Sul, Rio Grande Do Sul, Brazil
Oncoclínica
🇧🇷Rio de Janeiro, Brazil
Centro Regional Integrado de Oncologia (CRIO)
🇧🇷Fortaleza, Ceará, Brazil
Instituto Nacional do Câncer
🇧🇷Rio de Janeiro, Brazil
Centro de Pesquisa Instituto do Câncer Arnaldo Vieira de Carvalho
🇧🇷São Paulo, Brazil
Hospital São Vicente de Paulo
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Instituto de Pesquisa Clínicas para Estudos Multicêntricos da UCS
🇧🇷Caxias do Sul, Rio Grande Do Sul, Brazil
Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer
🇧🇷Natal, Rio Grande Do Norte, Brazil
Núcleo de Oncologia da Bahia
🇧🇷Salvador, Bahia, Brazil
Grupo de Estudos em Pesquisa de Pelotas
🇧🇷Pelotas, Rio Grande Do Sul, Brazil
CPO - Pucrs
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital da Cidade de Passo Fundo - Clínica CITO
🇧🇷Passo Fundo, Rio Grande Do Sul, Brazil
Novos Tratamentos em Câncer - Hospital Santa Casa de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Clínica AMO
🇧🇷Salvador, Bahia, Brazil
Hospital Jardim Amália
🇧🇷Volta Redonda, Rio De Janeiro, Brazil
Centro de Pesquisa Clínica do Hospital Israelita Albert Einstein
🇧🇷São Paulo, Brazil
Unidade de Pesquisa Clínica/Hospital de Clínicas da UFG
🇧🇷Goiânia, Goiás, Brazil
Instituto Oncológico de Ribeirão Preto - InORP
🇧🇷Ribeirão Preto, São Paulo, Brazil
CEPON
🇧🇷Florianópolis, Santa Catarina, Brazil
Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo Jorge
🇧🇷Goiânia, Goiás, Brazil
Unidade de Pesquisa Clínica do Hospital do Câncer de Londrina
🇧🇷Londrina, Paraná, Brazil
Clínica de Neoplasias Litoral - Centro de Novos Tratamentos Itajaí
🇧🇷Itajaí, Santa Catarina, Brazil