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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

The principal goal of this study is to describe the epidemiology of breast cancer in the Brazilian population. Other specific goals are:

• 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.

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil
    • Instituto Nacional do Cancer
  • Rio de Janeiro, Brazil
    • Oncoclínica
  • São Paulo, Brazil
    • Hospital AC Camargo
  • São Paulo, Brazil
    • Centro de Pesquisa Clínica do Hospital Israelita Albert Einstein
  • São Paulo, Brazil
    • Centro de Pesquisa Instituto do Câncer Arnaldo Vieira de Carvalho
  • Bahia
    • Salvador, Bahia, Brazil
      • Clinica AMO
    • Salvador, Bahia, Brazil
      • Nucleo de Oncologia da Bahia
  • Ceará
    • Fortaleza, Ceará, Brazil
      • Centro Regional Integrado de Oncologia (CRIO)
  • Goiás
    • Goiânia, Goiás, 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
  • Paraná
    • Londrina, Paraná, Brazil
      • Unidade de Pesquisa Clínica do Hospital do Câncer de Londrina
  • Rio De Janeiro
    • Volta Redonda, Rio De Janeiro, Brazil
      • Hospital Jardim Amália
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil
      • Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer
  • Rio Grande Do Sul
    • Caxias do Sul, Rio Grande Do Sul, Brazil
      • Centro de Pesquisas da Serra Gaúcha
    • Caxias do Sul, Rio Grande Do Sul, Brazil
      • Instituto de Pesquisa Clínicas para Estudos Multicêntricos da UCS
    • Passo Fundo, Rio Grande Do Sul, Brazil
      • Hospital Sao Vicente de Paulo
    • Passo Fundo, Rio Grande Do Sul, Brazil
      • Hospital da Cidade de Passo Fundo - Clínica CITO
    • Pelotas, Rio Grande Do Sul, Brazil
      • Grupo de Estudos em Pesquisa de Pelotas
    • Porto Alegre, 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
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil
      • CEPON
    • Itajaí, Santa Catarina, Brazil
      • Clínica de Neoplasias Litoral - Centro de Novos Tratamentos Itajaí
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil
      • Instituto Oncológico de Ribeirão Preto - InORP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Woman ≥ 18 years old with recent diagnosis of breast cancer

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Description of the epidemiology of breast cancer in the Brazilian population	Annually, during 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the socioeconomical characteristics of the Brazilian population with breast cancer		Annually, during 5 years
Characterization of the immunophenotypic markers of the tumor	estrogen receptor, progesterone receptor, HER2, Ki67	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
Initial treatment for breast cancer of Brazilian patients		Annually, during 5 years
Type of palliative treatment for metastasis or recurrent breast cancer in Brazilian patients		Annually, during 5 years
Clinical outcome of Brazilian breast cancer patients		Annually, during 5 years
Types of clinical complications displayed by breast cancer Brazilian patients		Annually, during 5 years
Characterization of exterior factors that may impact clinical outcome of breast cancer Brazilian patients		Annually, during 5 years

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Collaborators: Ministry of Health, Brazil; Avon Institute
• Investigators: Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Lancet. 2015 Mar 14;385(9972):946.
• 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.
• 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.
• 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.
• 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.
• Lohman TG, Roche AF, Martorell R. Anthropometric standardization reference manual. Illinois: A division of human Kinetics Publishers Inc, 1988.
• 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: GBECAM 0115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED