Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

February 22, 2017 updated by: Latin American Cooperative Oncology Group
The purpose of this study is to describe demographics and socioeconomics characteristics associated to the diagnosis of metastatic breast cancer in Brazil.

Study Overview

Status

Completed

Conditions

Detailed Description

The primary aim of this study is to characterize patients and treatments of metastatic breast cancer in Brazil. Other specific aims are:

  • to describe patients demographics and socioeconomic characteristics
  • to describe the BC pathological characterization
  • to describe treatment (describe each treatment with dates start-end, cycles, dosing, sequence and line of treatment, reason for discontinuation)
  • to analyze patients outcome (time to progression, site of metastasis, progression free survival (PFS), overall survival (OS), skeletal related events (SRE))

Study Type

Observational

Enrollment (Actual)

767

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Instituto Nacional do Cancer
      • São Paulo, Brazil
        • Instituto Brasileiro de Controle do Cancer - ibcc
      • São Paulo, Brazil
        • ICESP
      • São Paulo, Brazil
        • Hospital AC Camargo
      • São Paulo, Brazil
        • Hospital Sao Jose
    • Bahia
      • Salvador, Bahia, Brazil
        • Clinica AMO
      • Salvador, Bahia, Brazil
        • Clínica CEHON
      • Salvador, Bahia, Brazil
        • Nucleo de Oncologia da Bahia - NOB
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Centro Regional Integrado de Oncologia (CRIO)
      • Fortaleza, Ceará, Brazil
        • Hospital Haroldo Joaçaba Instituto do Câncer do Ceará
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil
        • Oncovida
    • Rio Grande do Sul
      • Bento Gonçalves, Rio Grande do Sul, Brazil
        • Hospital Tacchini
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Hospital Moinhos de Vento
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil
        • CPO - Pucrs
      • Porto Alegre, Rio Grande do Sul, Brazil
        • Hospital Mae de Deus
      • Santo André, Rio Grande do Sul, Brazil
        • Centro de Pesquisas em Hematologia e Oncologia
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil
        • Centro de Pesquisas Oncológicas - CEPON
      • Itajaí, Santa Catarina, Brazil
        • Centro de Novos Tratamentos de Itajaí
    • São Paulo
      • Barretos, São Paulo, Brazil
        • Hospital do Cancer de Barretos
      • Jaú, São Paulo, Brazil
        • Hospital Amaral Carvalho
      • Ribeirão Preto, São Paulo, Brazil
        • InORP
      • Rio Claro, São Paulo, Brazil
        • Centro de Oncologia e Hematologia de Rio Claro
      • Santo André, São Paulo, Brazil
        • IEP São Lucas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women >18 years old, patients diagnosed with metastatic breast cancer in the year of 2012 in Brazil

Description

Inclusion Criteria:

  • Women > 18 years old
  • Patients diagnosed with de novo or recurrent metastatic breast cancer during the period of January to December 2012
  • Any invasive breast cancer histology and subtype

Exclusion Criteria:

  • Male breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Description of sociodemographic and socioeconomics characteristics associated to diagnostic and treatment of metastatic breast cancer in Brazil
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Description of demographic characteristics of metastatic breast cancer patients
Time Frame: 8 months
8 months
The clinical and pathological characteristics of patients with metastatic breast cancer
Time Frame: 8 months
8 months
Prior treatment for breast cancer before metastatic disease
Time Frame: 8 months
8 months
The description of the clinical outcome of the patient diagnosed with metastatic breast cancer
Time Frame: 8 months
8 months
Type of treatment after the diagnosis of metastatic breast cancer
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Cooperative Oncology Group

Collaborators

Novartis

Investigators

  • Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 0312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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