Clinical trial NCT02663973: Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III
Official title: Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast cancer
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
name: Avon Institute
First posted: 2016-01-26
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman ≥ 18 years old with recent diagnosis of breast cancer

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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Description of the epidemiology of breast cancer in the Brazilian population
timeFrame: Annually, during 5 years
Secondary outcomes:
measure: Description of the socioeconomical characteristics of the Brazilian population with breast cancer
timeFrame: Annually, during 5 years
measure: Characterization of the immunophenotypic markers of the tumor
timeFrame: Annually, during 5 years
measure: Classification of breast cancer staging
timeFrame: Annually, during 5 years
measure: Description of screening tests of breast cancer patients in Brazil
timeFrame: Annually, during 5 years
measure: Main symptoms presented by patients with breast cancer in Brazil
timeFrame: Annually, during 5 years
measure: Initial treatment for breast cancer of Brazilian patients
timeFrame: Annually, during 5 years
measure: Type of palliative treatment for metastasis or recurrent breast cancer in Brazilian patients
timeFrame: Annually, during 5 years
measure: Clinical outcome of Brazilian breast cancer patients
timeFrame: Annually, during 5 years
measure: Types of clinical complications displayed by breast cancer Brazilian patients
timeFrame: Annually, during 5 years
measure: Characterization of exterior factors that may impact clinical outcome of breast cancer Brazilian patients
timeFrame: Annually, during 5 years
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Clínica AMO
state: Bahia
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia (CRIO)
state: Ceará
city: Goiânia
country: Brazil
facility: Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo Jorge
state: Goiás
city: Goiânia
country: Brazil
facility: Unidade de Pesquisa Clínica/Hospital de Clínicas da UFG
state: Goiás
city: Londrina
country: Brazil
facility: Unidade de Pesquisa Clínica do Hospital do Câncer de Londrina
state: Paraná
city: Volta Redonda
country: Brazil
facility: Hospital Jardim Amália
state: Rio De Janeiro
city: Natal
country: Brazil
facility: Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer
state: Rio Grande Do Norte
city: Caxias do Sul
country: Brazil
facility: Centro de Pesquisas da Serra Gaúcha
state: Rio Grande Do Sul
city: Caxias do Sul
country: Brazil
facility: Instituto de Pesquisa Clínicas para Estudos Multicêntricos da UCS
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo - Clínica CITO
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: Grupo de Estudos em Pesquisa de Pelotas
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: CPO - Pucrs
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Novos Tratamentos em Câncer - Hospital Santa Casa de Porto Alegre
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: CEPON
state: Santa Catarina
city: Itajaí
country: Brazil
facility: Clínica de Neoplasias Litoral - Centro de Novos Tratamentos Itajaí
state: Santa Catarina
city: Ribeirão Preto
country: Brazil
facility: Instituto Oncológico de Ribeirão Preto - InORP
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Câncer
city: Rio de Janeiro
country: Brazil
facility: Oncoclínica
city: São Paulo
country: Brazil
facility: Centro de Pesquisa Clínica do Hospital Israelita Albert Einstein
city: São Paulo
country: Brazil
facility: Centro de Pesquisa Instituto do Câncer Arnaldo Vieira de Carvalho
city: São Paulo
country: Brazil
facility: Hospital AC Camargo
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky, MD
role: STUDY_DIRECTOR
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