Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III

NCT02663973 | Completed

• 1 other identifier: GBECAM 0115
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 24

Brief Summary

The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population

Conditions

Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• Description of the epidemiology of breast cancer in the Brazilian population

  Annually, during 5 years

Secondary Outcomes (10)

• Description of the socioeconomical characteristics of the Brazilian population with breast cancer

  Annually, during 5 years

• Characterization of the immunophenotypic markers of the tumor

  Annually, during 5 years

• Classification of breast cancer staging

  Annually, during 5 years

• Description of screening tests of breast cancer patients in Brazil

  Annually, during 5 years

• Main symptoms presented by patients with breast cancer in Brazil

  Annually, during 5 years

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

Woman ≥ 18 years old with recent diagnosis of breast cancer

You may qualify if:

• Woman ≥ 18 years old
• Invasive breast cancer stage I to IV proven by histology or cytology
• Patients with new pathological diagnosis of invasive primary BC after the site activation date
• Pathological diagnosis of invasive breast cancer during recruitment (6 months before center activation or until 3000 patients included)
• New primary cancer on the same breast or contralateral breast.
• Patient's medical chart is available and adequate for data collection
• Patient properly signed the informed consent form

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Ministry of Health, Brazil: collaborator
• Avon Institute: collaborator

Study Sites (24)

Centro Regional Integrado de Oncologia (CRIO)

Fortaleza, Ceará, Brazil

Location

Clínica AMO

Salvador, Estado de Bahia, Brazil

Location

Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Location

Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo Jorge

Goiânia, Goiás, Brazil

Location

Unidade de Pesquisa Clínica/Hospital de Clínicas da UFG

Goiânia, Goiás, Brazil

Location

Unidade de Pesquisa Clínica do Hospital do Câncer de Londrina

Londrina, Paraná, Brazil

Location

Hospital Jardim Amália

Volta Redonda, Rio de Janeiro, Brazil

Location

Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, Brazil

Location

Centro de Pesquisas da Serra Gaúcha

Caxias do Sul, Rio Grande do Sul, Brazil

Location

Instituto de Pesquisa Clínicas para Estudos Multicêntricos da UCS

Caxias do Sul, Rio Grande do Sul, Brazil

Location

Hospital da Cidade de Passo Fundo - Clínica CITO

Passo Fundo, Rio Grande do Sul, Brazil

Location

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Location

Grupo de Estudos em Pesquisa de Pelotas

Pelotas, Rio Grande do Sul, Brazil

Location

CPO - Pucrs

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Location

Novos Tratamentos em Câncer - Hospital Santa Casa de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

CEPON

Florianópolis, Santa Catarina, Brazil

Location

Clínica de Neoplasias Litoral - Centro de Novos Tratamentos Itajaí

Itajaí, Santa Catarina, Brazil

Location

Instituto Oncológico de Ribeirão Preto - InORP

Ribeirão Preto, São Paulo, Brazil

Location

Instituto Nacional do Câncer

Rio de Janeiro, Brazil

Location

Oncoclínica

Rio de Janeiro, Brazil

Location

Centro de Pesquisa Clínica do Hospital Israelita Albert Einstein

São Paulo, Brazil

Location

Centro de Pesquisa Instituto do Câncer Arnaldo Vieira de Carvalho

São Paulo, Brazil

Location

Hospital AC Camargo

São Paulo, Brazil

Location

Related Publications (17)

• Allemani C, Weir HK, Carreira H, Harewood R, Spika D, Wang XS, Bannon F, Ahn JV, Johnson CJ, Bonaventure A, Marcos-Gragera R, Stiller C, Azevedo e Silva G, Chen WQ, Ogunbiyi OJ, Rachet B, Soeberg MJ, You H, Matsuda T, Bielska-Lasota M, Storm H, Tucker TC, Coleman MP; CONCORD Working Group. Global surveillance of cancer survival 1995-2009: analysis of individual data for 25,676,887 patients from 279 population-based registries in 67 countries (CONCORD-2). Lancet. 2015 Mar 14;385(9972):977-1010. doi: 10.1016/S0140-6736(14)62038-9. Epub 2014 Nov 26.

  PMID: 25467588 BACKGROUND

• Freitas-Junior R, Gonzaga CM, Freitas NM, Martins E, Dardes Rde C. Disparities in female breast cancer mortality rates in Brazil between 1980 and 2009. Clinics (Sao Paulo). 2012 Jul;67(7):731-7. doi: 10.6061/clinics/2012(07)05.

  PMID: 22892915 BACKGROUND

• Gonzaga CM, Freitas-Junior R, Souza MR, Curado MP, Freitas NM. Disparities in female breast cancer mortality rates between urban centers and rural areas of Brazil: ecological time-series study. Breast. 2014 Apr;23(2):180-7. doi: 10.1016/j.breast.2014.01.006. Epub 2014 Feb 4.

  PMID: 24503143 BACKGROUND

• Palmer JR, Viscidi E, Troester MA, Hong CC, Schedin P, Bethea TN, Bandera EV, Borges V, McKinnon C, Haiman CA, Lunetta K, Kolonel LN, Rosenberg L, Olshan AF, Ambrosone CB. Parity, lactation, and breast cancer subtypes in African American women: results from the AMBER Consortium. J Natl Cancer Inst. 2014 Sep 15;106(10):dju237. doi: 10.1093/jnci/dju237. Print 2014 Oct.

  PMID: 25224496 BACKGROUND

• Phipps AI, Chlebowski RT, Prentice R, McTiernan A, Wactawski-Wende J, Kuller LH, Adams-Campbell LL, Lane D, Stefanick ML, Vitolins M, Kabat GC, Rohan TE, Li CI. Reproductive history and oral contraceptive use in relation to risk of triple-negative breast cancer. J Natl Cancer Inst. 2011 Mar 16;103(6):470-7. doi: 10.1093/jnci/djr030. Epub 2011 Feb 23.

  PMID: 21346227 BACKGROUND

• Anderson KN, Schwab RB, Martinez ME. Reproductive risk factors and breast cancer subtypes: a review of the literature. Breast Cancer Res Treat. 2014 Feb;144(1):1-10. doi: 10.1007/s10549-014-2852-7. Epub 2014 Jan 30.

  PMID: 24477977 BACKGROUND

• Vona-Davis L, Howard-McNatt M, Rose DP. Adiposity, type 2 diabetes and the metabolic syndrome in breast cancer. Obes Rev. 2007 Sep;8(5):395-408. doi: 10.1111/j.1467-789X.2007.00396.x.

  PMID: 17716297 BACKGROUND

• Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423.

  PMID: 12711737 BACKGROUND

• Reeves GK, Pirie K, Beral V, Green J, Spencer E, Bull D; Million Women Study Collaboration. Cancer incidence and mortality in relation to body mass index in the Million Women Study: cohort study. BMJ. 2007 Dec 1;335(7630):1134. doi: 10.1136/bmj.39367.495995.AE. Epub 2007 Nov 6.

  PMID: 17986716 BACKGROUND

• Cleveland RJ, Eng SM, Abrahamson PE, Britton JA, Teitelbaum SL, Neugut AI, Gammon MD. Weight gain prior to diagnosis and survival from breast cancer. Cancer Epidemiol Biomarkers Prev. 2007 Sep;16(9):1803-11. doi: 10.1158/1055-9965.EPI-06-0889.

  PMID: 17855698 BACKGROUND

• Anders CK, Deal AM, Miller CR, Khorram C, Meng H, Burrows E, Livasy C, Fritchie K, Ewend MG, Perou CM, Carey LA. The prognostic contribution of clinical breast cancer subtype, age, and race among patients with breast cancer brain metastases. Cancer. 2011 Apr 15;117(8):1602-11. doi: 10.1002/cncr.25746. Epub 2010 Nov 29.

  PMID: 21472708 BACKGROUND

• Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.

  PMID: 10963602 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

• Lohman TG, Roche AF, Martorell R. Anthropometric standardization reference manual. Illinois: A division of human Kinetics Publishers Inc, 1988.

  BACKGROUND

• Werutsky G, Lopes M, de Jesus RG, Gazola AA, Pellegrini RA, Rebelatto TF, Freitas LVW, Heck AP, da Silva AF, Rodrigues MF, Gossling G, Giacomazzi J, Rocha MS, Rosa DD, Barrios CH, Cronemberger EH, Queiroz GS, Bines J, Simon SD, Fay AP. The impact of a breast cancer diagnosis on marital outcomes and factors associated with divorce and separation. Rev Bras Ginecol Obstet. 2024 Jun 27;46:e-rbgo60. doi: 10.61622/rbgo/2024rbgo60. eCollection 2024.

  PMID: 38994465 DERIVED

• Maschmann RM, De Jesus RG, Werutsky G, Rebelatto TF, Queiroz G, Simon SD, Bines J, Barrios CHE, Rosa DD. Time interval between diagnosis to treatment of breast cancer and the impact of health insurance coverage: a sub analysis of the AMAZONA III Study (GBECAM 0115). Breast Cancer Res Treat. 2023 Feb;198(1):123-130. doi: 10.1007/s10549-022-06809-8. Epub 2022 Dec 31.

  PMID: 36586038 DERIVED

• Franzoi MA, Rosa DD, Zaffaroni F, Werutsky G, Simon S, Bines J, Barrios C, Cronemberger E, Queiroz GS, Cordeiro de Lima V, Junior RF, Couto J, Emerenciano K, Resende H, Crocamo S, Reinert T, Van Eyli B, Neron Y, Dybal V, Lazaretti N, de Cassia Costamillan R, Pinto de Andrade DA, Mathias C, Vacaro GZ, Borges G, Morelle A, Filho CAS, Mano M, Liedke PER. Advanced Stage at Diagnosis and Worse Clinicopathologic Features in Young Women with Breast Cancer in Brazil: A Subanalysis of the AMAZONA III Study (GBECAM 0115). J Glob Oncol. 2019 Nov;5:1-10. doi: 10.1200/JGO.19.00263.

  PMID: 31730380 DERIVED

Related Links

• World Health Organization. GLOBOCAN 2012: cancer incidence and mortality worldwide. Accessed in Jan 8 2015.
• National Cancer Institute. Cancer treatment. Accessed in Jan 8 2015.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gustavo Werutsky, MD

  Latin American Cooperative Oncology Group

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 26, 2016
• Study Start: January 1, 2016
• Primary Completion: June 15, 2020
• Study Completion: April 1, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

BR (24)