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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663973
• Other study ID #: GBECAM 0115
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: April 1, 2021

Study information

• Verified date: June 2021
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: April 1, 2021
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
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	CEPON	Florianópolis	Santa Catarina
Brazil	Centro Regional Integrado de Oncologia (CRIO)	Fortaleza	Ceará
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	Clínica de Neoplasias Litoral - Centro de Novos Tratamentos Itajaí	Itajaí	Santa Catarina
Brazil	Unidade de Pesquisa Clínica do Hospital do Câncer de Londrina	Londrina	Paraná
Brazil	Centro de Pesquisa Clínica da Liga Norte Riograndense Contra o Câncer	Natal	Rio Grande Do Norte
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	Instituto Oncológico de Ribeirão Preto - InORP	Ribeirão Preto	São Paulo
Brazil	Instituto Nacional do Câncer	Rio de Janeiro
Brazil	Oncoclínica	Rio de Janeiro
Brazil	Clínica AMO	Salvador	Bahia
Brazil	Núcleo de Oncologia da Bahia	Salvador	Bahia
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	Hospital Jardim Amália	Volta Redonda	Rio De Janeiro

Sponsors (3)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Avon Institute, Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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). pii: dju237. doi: 10.1093/jnci/dju237. Print 2014 Oct. — View Citation

Perou CM, Sørlie 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, Lønning PE, Børresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. — View Citation

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. — View Citation

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. Epub 2007 Nov 6. — View Citation

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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the epidemiology of breast cancer in the Brazilian population		Annually, during 5 years
Secondary	Description of the socioeconomical characteristics of the Brazilian population with breast cancer		Annually, during 5 years
Secondary	Characterization of the immunophenotypic markers of the tumor	estrogen receptor, progesterone receptor, HER2, Ki67	Annually, during 5 years
Secondary	Classification of breast cancer staging		Annually, during 5 years
Secondary	Description of screening tests of breast cancer patients in Brazil		Annually, during 5 years
Secondary	Main symptoms presented by patients with breast cancer in Brazil		Annually, during 5 years
Secondary	Initial treatment for breast cancer of Brazilian patients		Annually, during 5 years
Secondary	Type of palliative treatment for metastasis or recurrent breast cancer in Brazilian patients		Annually, during 5 years
Secondary	Clinical outcome of Brazilian breast cancer patients		Annually, during 5 years
Secondary	Types of clinical complications displayed by breast cancer Brazilian patients		Annually, during 5 years
Secondary	Characterization of exterior factors that may impact clinical outcome of breast cancer Brazilian patients		Annually, during 5 years

External Links

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