Prospective Evaluation of Breast Cancer at Brazilian Institutions - Project AMAZONA III
NCT ID: NCT02663973
Last Updated: 2021-06-15
Study Results
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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COMPLETED
3000 participants
OBSERVATIONAL
2016-01-01
2021-04-01
Brief Summary
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Detailed Description
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* To evaluate the demographic and socio-demographic profile, comorbidities and reproductive risks, anthropometric profile and family history.
* Characterize the breast tumors immunophenotype through anatomopathological data, such as: tumor grade, estrogen receptor, progesterone receptor, HER2, Ki67.
* Describe the screening tests, main symptoms and cancer stage in the moment of the diagnosis.
* Describe the initial cancer treatment and locally advanced such as surgery, radiotherapy, chemotherapy and endocrine therapy.
* Describe palliative treatment for recurrent or metastatic breast cancer: chemotherapy, radiotherapy, biphosphonate, and others.
* Evaluate the clinical outcomes such as: local or diffuse relapse, period of time until progression to metastatic cancer, global lifespan and specific breast cancer lifespan.
* Evaluate clinical complications of the metastatic disease, such as: brain metastasis, spinal cord compression, skeletal related events.
* Analyze the demographical and socio-economical characteristics, clinical-pathological characteristics of the tumor, treatment, clinical outcomes, type of institution (private/public), and other factors that may impact clinical outcome.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Ministry of Health, Brazil
OTHER_GOV
Avon Institute
UNKNOWN
Latin American Cooperative Oncology Group
OTHER
Responsible Party
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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
Clínica AMO
Salvador, Estado de Bahia, Brazil
Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, Brazil
Centro de Pesquisa do Setor de Ginecologia e Mama do Hospital Araújo Jorge
Goiânia, Goiás, Brazil
Unidade de Pesquisa Clínica/Hospital de Clínicas da UFG
Goiânia, Goiás, Brazil
Unidade de Pesquisa Clínica do Hospital do Câncer de Londrina
Londrina, Paraná, Brazil
Hospital Jardim Amália
Volta Redonda, Rio de Janeiro, Brazil
Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Centro de Pesquisas da Serra Gaúcha
Caxias do Sul, Rio Grande do Sul, Brazil
Instituto de Pesquisa Clínicas para Estudos Multicêntricos da UCS
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital da Cidade de Passo Fundo - Clínica CITO
Passo Fundo, Rio Grande do Sul, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Grupo de Estudos em Pesquisa de Pelotas
Pelotas, Rio Grande do Sul, Brazil
CPO - Pucrs
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Novos Tratamentos em Câncer - Hospital Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
CEPON
Florianópolis, Santa Catarina, Brazil
Clínica de Neoplasias Litoral - Centro de Novos Tratamentos Itajaí
Itajaí, Santa Catarina, Brazil
Instituto Oncológico de Ribeirão Preto - InORP
Ribeirão Preto, São Paulo, Brazil
Instituto Nacional do Câncer
Rio de Janeiro, , Brazil
Oncoclínica
Rio de Janeiro, , Brazil
Centro de Pesquisa Clínica do Hospital Israelita Albert Einstein
São Paulo, , Brazil
Centro de Pesquisa Instituto do Câncer Arnaldo Vieira de Carvalho
São Paulo, , Brazil
Hospital AC Camargo
São Paulo, , Brazil
Countries
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References
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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.
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.
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.
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.
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.
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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.
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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.
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.
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.
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.
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.
Lohman TG, Roche AF, Martorell R. Anthropometric standardization reference manual. Illinois: A division of human Kinetics Publishers Inc, 1988.
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.
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.
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.
Related Links
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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.
Other Identifiers
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GBECAM 0115
Identifier Type: -
Identifier Source: org_study_id
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