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Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

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ClinicalTrials.gov Identifier: NCT02662868
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

Brief Summary:
The purpose of this study is to describe demographics and socioeconomics characteristics associated to the diagnosis of metastatic breast cancer in Brazil.

Condition or disease
Metastatic Breast Cancer

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
Actual Enrollment : 767 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments
Study Start Date : June 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Description of sociodemographic and socioeconomics characteristics associated to diagnostic and treatment of metastatic breast cancer in Brazil [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Description of demographic characteristics of metastatic breast cancer patients [ Time Frame: 8 months ]
  2. The clinical and pathological characteristics of patients with metastatic breast cancer [ Time Frame: 8 months ]
  3. Prior treatment for breast cancer before metastatic disease [ Time Frame: 8 months ]
  4. The description of the clinical outcome of the patient diagnosed with metastatic breast cancer [ Time Frame: 8 months ]
  5. Type of treatment after the diagnosis of metastatic breast cancer [ Time Frame: 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women >18 years old, patients diagnosed with metastatic breast cancer in the year of 2012 in Brazil
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662868


Locations
Brazil
Clínica AMO
Salvador, Bahia, Brazil
Clínica CEHON
Salvador, Bahia, Brazil
Núcleo de Oncologia da Bahia - NOB
Salvador, Bahia, Brazil
Centro Regional Integrado de Oncologia (CRIO)
Fortaleza, Ceará, Brazil
Hospital Haroldo Joaçaba Instituto do Câncer do Ceará
Fortaleza, Ceará, Brazil
Oncovida
Brasília, Distrito Federal, Brazil
Hospital Tacchini
Bento Gonçalves, Rio Grande do Sul, Brazil
CPO - Pucrs
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisas em Hematologia e Oncologia
Santo André, Rio Grande do Sul, Brazil
Centro de Pesquisas Oncológicas - CEPON
Florianópolis, Santa Catarina, Brazil
Centro de Novos Tratamentos de Itajaí
Itajaí, Santa Catarina, Brazil
Hospital do Câncer de Barretos
Barretos, São Paulo, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
InORP
Ribeirão Preto, São Paulo, Brazil
Centro de Oncologia e Hematologia de Rio Claro
Rio Claro, São Paulo, Brazil
IEP São Lucas
Santo André, São Paulo, Brazil
Instituto Nacional do Câncer
Rio de Janeiro, Brazil
Hospital AC Camargo
São Paulo, Brazil
Hospital São José
São Paulo, Brazil
ICESP
São Paulo, Brazil
Instituto Brasileiro de Controle do Câncer - IBCC
São Paulo, Brazil
Sponsors and Collaborators
Latin American Cooperative Oncology Group
Novartis
Investigators
Study Director: Gustavo Werutsky, MD Latin American Cooperative Oncology Group

Publications:

Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT02662868     History of Changes
Other Study ID Numbers: LACOG 0312
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Latin American Cooperative Oncology Group:
Breast cancer
Metastasis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases