Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

NCT02662868 | Completed

• 1 other identifier: LACOG 0312
• Study Type: observational
• Target: 767
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer; Metastasis

Outcome Measures

Primary Outcomes (1)

• Description of sociodemographic and socioeconomics characteristics associated to diagnostic and treatment of metastatic breast cancer in Brazil

  8 months

Secondary Outcomes (5)

• Description of demographic characteristics of metastatic breast cancer patients

  8 months

• The clinical and pathological characteristics of patients with metastatic breast cancer

  8 months

• Prior treatment for breast cancer before metastatic disease

  8 months

• The description of the clinical outcome of the patient diagnosed with metastatic breast cancer

  8 months

• Type of treatment after the diagnosis of metastatic breast cancer

  8 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Male breast cancer

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Novartis: collaborator

Study Sites (24)

Centro Regional Integrado de Oncologia (CRIO)

Fortaleza, Ceará, Brazil

Location

Hospital Haroldo Joaçaba Instituto do Câncer do Ceará

Fortaleza, Ceará, Brazil

Location

Clínica AMO

Salvador, Estado de Bahia, Brazil

Location

Clínica CEHON

Salvador, Estado de Bahia, Brazil

Location

Núcleo de Oncologia da Bahia - NOB

Salvador, Estado de Bahia, Brazil

Location

Oncovida

Brasília, Federal District, Brazil

Location

Instituto Nacional do Câncer

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital Tacchini

Bento Gonçalves, Rio Grande do Sul, Brazil

Location

CPO - Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Location

Centro de Pesquisas em Hematologia e Oncologia

Santo André, Rio Grande do Sul, Brazil

Location

Centro de Pesquisas Oncológicas - CEPON

Florianópolis, Santa Catarina, Brazil

Location

Centro de Novos Tratamentos de Itajaí

Itajaí, Santa Catarina, Brazil

Location

Hospital do Câncer de Barretos

Barretos, São Paulo, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Location

InORP

Ribeirão Preto, São Paulo, Brazil

Location

Centro de Oncologia e Hematologia de Rio Claro

Rio Claro, São Paulo, Brazil

Location

IEP São Lucas

Santo André, São Paulo, Brazil

Location

Hospital AC Camargo

São Paulo, São Paulo, Brazil

Location

Hospital São José

São Paulo, São Paulo, Brazil

Location

ICESP

São Paulo, São Paulo, Brazil

Location

Instituto Brasileiro de Controle do Câncer - IBCC

São Paulo, São Paulo, Brazil

Location

Related Publications (12)

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• Autier P, Boniol M, La Vecchia C, Vatten L, Gavin A, Hery C, Heanue M. Disparities in breast cancer mortality trends between 30 European countries: retrospective trend analysis of WHO mortality database. BMJ. 2010 Aug 11;341:c3620. doi: 10.1136/bmj.c3620.

  PMID: 20702548 BACKGROUND

• Malvezzi M, Bertuccio P, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2014. Ann Oncol. 2014 Aug;25(8):1650-6. doi: 10.1093/annonc/mdu138. Epub 2014 Apr 23.

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• Lee BL, Liedke PE, Barrios CH, Simon SD, Finkelstein DM, Goss PE. Breast cancer in Brazil: present status and future goals. Lancet Oncol. 2012 Mar;13(3):e95-e102. doi: 10.1016/S1470-2045(11)70323-0.

  PMID: 22381937 BACKGROUND

• Liedke PE, Finkelstein DM, Szymonifka J, Barrios CH, Chavarri-Guerra Y, Bines J, Vasconcelos C, Simon SD, Goss PE. Outcomes of breast cancer in Brazil related to health care coverage: a retrospective cohort study. Cancer Epidemiol Biomarkers Prev. 2014 Jan;23(1):126-33. doi: 10.1158/1055-9965.EPI-13-0693. Epub 2013 Oct 28.

  PMID: 24165578 BACKGROUND

• Regierer AC, Wolters R, Ufen MP, Weigel A, Novopashenny I, Kohne CH, Samonigg H, Eucker J, Possinger K, Wischnewsky MB. An internally and externally validated prognostic score for metastatic breast cancer: analysis of 2269 patients. Ann Oncol. 2014 Mar;25(3):633-638. doi: 10.1093/annonc/mdt539. Epub 2013 Dec 23.

  PMID: 24368402 BACKGROUND

• Andre F, Neven P, Marinsek N, Zhang J, Baladi JF, Degun R, Benelli G, Saletan S, Jerusalem G. Disease management patterns for postmenopausal women in Europe with hormone-receptor-positive, human epidermal growth factor receptor-2 negative advanced breast cancer. Curr Med Res Opin. 2014 Jun;30(6):1007-16. doi: 10.1185/03007995.2014.887002. Epub 2014 Feb 3.

  PMID: 24490834 BACKGROUND

• Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9. doi: 10.1056/NEJMoa1109653. Epub 2011 Dec 7.

  PMID: 22149876 BACKGROUND

• Yardley DA, Noguchi S, Pritchard KI, Burris HA 3rd, Baselga J, Gnant M, Hortobagyi GN, Campone M, Pistilli B, Piccart M, Melichar B, Petrakova K, Arena FP, Erdkamp F, Harb WA, Feng W, Cahana A, Taran T, Lebwohl D, Rugo HS. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013 Oct;30(10):870-84. doi: 10.1007/s12325-013-0060-1. Epub 2013 Oct 25.

  PMID: 24158787 BACKGROUND

• Campone M, Bachelot T, Gnant M, Deleu I, Rugo HS, Pistilli B, Noguchi S, Shtivelband M, Pritchard KI, Provencher L, Burris HA 3rd, Hart L, Melichar B, Hortobagyi GN, Arena F, Baselga J, Panneerselvam A, Heniquez A, El-Hashimyt M, Taran T, Sahmoud T, Piccart M. Effect of visceral metastases on the efficacy and safety of everolimus in postmenopausal women with advanced breast cancer: subgroup analysis from the BOLERO-2 study. Eur J Cancer. 2013 Aug;49(12):2621-32. doi: 10.1016/j.ejca.2013.04.011. Epub 2013 Jun 1.

  PMID: 23735704 BACKGROUND

• Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Dieras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1.

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• Baselga J, Cortes J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM; CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012 Jan 12;366(2):109-19. doi: 10.1056/NEJMoa1113216. Epub 2011 Dec 7.

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MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gustavo Werutsky, MD

  Latin American Cooperative Oncology Group

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 26, 2016
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

BR (24)