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Completed

NCT Number: NCT02663973

Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III

The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centro Regional Integrado de Oncologia (CRIO), Fortaleza, Ceará, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Description of the epidemiology of breast cancer in the Brazilian population

    Time frame: Annually, during 5 years

Secondary outcomes

  1. Description of the socioeconomical characteristics of the Brazilian population with breast cancer

    Time frame: Annually, during 5 years

  2. Characterization of the immunophenotypic markers of the tumor

    Time frame: Annually, during 5 years

    estrogen receptor, progesterone receptor, HER2, Ki67

  3. Classification of breast cancer staging

    Time frame: Annually, during 5 years

  4. Description of screening tests of breast cancer patients in Brazil

    Time frame: Annually, during 5 years

  5. Main symptoms presented by patients with breast cancer in Brazil

    Time frame: Annually, during 5 years

  6. Initial treatment for breast cancer of Brazilian patients

    Time frame: Annually, during 5 years

  7. Type of palliative treatment for metastasis or recurrent breast cancer in Brazilian patients

    Time frame: Annually, during 5 years

  8. Clinical outcome of Brazilian breast cancer patients

    Time frame: Annually, during 5 years

  9. Types of clinical complications displayed by breast cancer Brazilian patients

    Time frame: Annually, during 5 years

  10. Characterization of exterior factors that may impact clinical outcome of breast cancer Brazilian patients

    Time frame: Annually, during 5 years

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • Avon Institute
  • Ministry of Health, Brazil

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Jan 26, 2016
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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