Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

NCT ID: NCT02662868

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

767 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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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))

Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Latin American Cooperative Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gustavo Werutsky, MD

Role: STUDY_DIRECTOR

Latin American Cooperative Oncology Group

Locations

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Centro Regional Integrado de Oncologia (CRIO)

Fortaleza, Ceará, Brazil

Site Status

Hospital Haroldo Joaçaba Instituto do Câncer do Ceará

Fortaleza, Ceará, Brazil

Site Status

Clínica AMO

Salvador, Estado de Bahia, Brazil

Site Status

Clínica CEHON

Salvador, Estado de Bahia, Brazil

Site Status

Núcleo de Oncologia da Bahia - NOB

Salvador, Estado de Bahia, Brazil

Site Status

Oncovida

Brasília, Federal District, Brazil

Site Status

Instituto Nacional do Câncer

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Hospital Tacchini

Bento Gonçalves, Rio Grande do Sul, Brazil

Site Status

CPO - Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Centro de Pesquisas em Hematologia e Oncologia

Santo André, Rio Grande do Sul, Brazil

Site Status

Centro de Pesquisas Oncológicas - CEPON

Florianópolis, Santa Catarina, Brazil

Site Status

Centro de Novos Tratamentos de Itajaí

Itajaí, Santa Catarina, Brazil

Site Status

Hospital do Câncer de Barretos

Barretos, São Paulo, Brazil

Site Status

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status

InORP

Ribeirão Preto, São Paulo, Brazil

Site Status

Centro de Oncologia e Hematologia de Rio Claro

Rio Claro, São Paulo, Brazil

Site Status

IEP São Lucas

Santo André, São Paulo, Brazil

Site Status

Hospital AC Camargo

São Paulo, São Paulo, Brazil

Site Status

Hospital São José

São Paulo, São Paulo, Brazil

Site Status

ICESP

São Paulo, São Paulo, Brazil

Site Status

Instituto Brasileiro de Controle do Câncer - IBCC

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 24343171 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20702548 (View on PubMed)

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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PMID: 24759568 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

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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.

Reference Type BACKGROUND
PMID: 24368402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24490834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22149876 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24158787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23735704 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 22149875 (View on PubMed)

Other Identifiers

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LACOG 0312

Identifier Type: -

Identifier Source: org_study_id

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