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Metastatic Breast CancerNCT02662868

Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

An observational study of Metastatic Breast Cancer, run by Latin American Cooperative Oncology Group at 24 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
How many people
767 participants
Where
24 sitesBrazil
Study dates
Jun 2015to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Male breast cancer

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Brazil24 sites

  • Hospital do Câncer de Barretos

    Barretos, São Paulo

  • Hospital Tacchini

    Bento Gonçalves, Rio Grande do Sul

  • Oncovida

    Brasília, Federal District

  • Centro de Pesquisas Oncológicas - CEPON

    Florianópolis, Santa Catarina

  • Centro Regional Integrado de Oncologia (CRIO)

    Fortaleza, Ceará

  • Hospital Haroldo Joaçaba Instituto do Câncer do Ceará

    Fortaleza, Ceará

  • Centro de Novos Tratamentos de Itajaí

    Itajaí, Santa Catarina

  • Hospital Amaral Carvalho

    Jaú, São Paulo

  • CPO - Pucrs

    Porto Alegre, Rio Grande do Sul

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul

  • Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul

  • InORP

    Ribeirão Preto, São Paulo

  • Centro de Oncologia e Hematologia de Rio Claro

    Rio Claro, São Paulo

  • Instituto Nacional do Câncer

    Rio de Janeiro, Rio de Janeiro

  • Clínica AMO

    Salvador, Estado de Bahia

  • Clínica CEHON

    Salvador, Estado de Bahia

  • Núcleo de Oncologia da Bahia - NOB

    Salvador, Estado de Bahia

  • Centro de Pesquisas em Hematologia e Oncologia

    Santo André, Rio Grande do Sul

  • IEP São Lucas

    Santo André, São Paulo

  • Hospital AC Camargo

    São Paulo, São Paulo

  • Hospital São José

    São Paulo, São Paulo

  • ICESP

    São Paulo, São Paulo

  • Instituto Brasileiro de Controle do Câncer - IBCC

    São Paulo, São Paulo

Other trials in Brazil

About this study

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))
Keywords
Breast cancer, Metastasis
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8 months

Secondary outcomes (5)

  1. Description of demographic characteristics of metastatic breast cancer patients

    Measured: 8 months

  2. The clinical and pathological characteristics of patients with metastatic breast cancer

    Measured: 8 months

  3. Prior treatment for breast cancer before metastatic disease

    Measured: 8 months

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

    Measured: 8 months

  5. Type of treatment after the diagnosis of metastatic breast cancer

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionJun 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
767 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02662868
Sponsor's protocol ID
LACOG 0312
Status last verified
Feb 2017
First submitted
15 Jan 2016
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No

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.

    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.

    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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer, run by Latin American Cooperative Oncology Group at 24 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Description of sociodemographic and socioeconomics characteristics associated to diagnostic and treatment of metastatic breast cancer in Brazil (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02662868, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.

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