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CompletedNCT02662868Updated Feb 23, 2017

Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

An observational study in Metastatic Breast Cancer, sponsored by Latin American Cooperative Oncology Group. Completed at 24 sites in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Latin American Cooperative Oncology Group · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
767
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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))
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Conditions studied

  • Metastatic Breast Cancer

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Keywords

  • Breast cancer
  • Metastasis
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 767 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Latin American Cooperative Oncology Group is the lead sponsor of 46 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • Male breast cancer
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
767 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Time frame: 8 months

Secondary outcomes

  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

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Study locations

24 sites
  • 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
08

References and documents

Publications

  • Edwards BK, Noone AM, Mariotto AB, Simard EP, Boscoe FP, Henley SJ, Jemal A, Cho H, Anderson RN, Kohler BA, Eheman CR, Ward EM. Annual Report to the Nation on the status of cancer, 1975-2010, featuring prevalence of comorbidity and impact on survival among persons with lung, colorectal, breast, or prostate cancer. Cancer. 2014 May 1;120(9):1290-314. doi: 10.1002/cncr.28509. Epub 2013 Dec 16. PubMed 24343171 ↗
  • 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. Erratum In: BMJ. 2010;341:c4480. LaVecchia, Carlo [corrected to La Vecchia, Carlo]. PubMed 20702548 ↗
  • 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. PubMed 24759568 ↗
  • 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. PubMed 22381937 ↗
  • 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. PubMed 24165578 ↗
  • 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. PubMed 24368402 ↗
  • 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. PubMed 24490834 ↗
  • 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. PubMed 22149876 ↗
  • 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. Erratum In: Adv Ther. 2014 Sep;31(9):1008-9. PubMed 24158787 ↗
  • 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. PubMed 23735704 ↗
  • 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. Erratum In: N Engl J Med. 2013 Jun 20;368(25):2442. PubMed 23020162 ↗
  • 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. PubMed 22149875 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02662868
Lead sponsor
Latin American Cooperative Oncology Group
Collaborators
Novartis
Responsible party
Sponsor
First posted
Jan 26, 2016
Start date
Jun 2015
Primary completion
Jun 2016
Completion
Dec 2016
Last update
Feb 23, 2017

Study contacts

Gustavo Werutsky, MD
study director · Latin American Cooperative Oncology Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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