Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

Metastatic Breast Cancer Clinical Trial

Official title:

Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662868
• Other study ID #: LACOG 0312
• Status: Completed
• Phase: N/A
• First received: January 15, 2016
• Last updated: February 22, 2017
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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))

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Male breast cancer

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Brazil	Hospital do Câncer de Barretos	Barretos	São Paulo
Brazil	Hospital Tacchini	Bento Gonçalves	Rio Grande do Sul
Brazil	Oncovida	Brasília	Distrito Federal
Brazil	Centro de Pesquisas Oncológicas - CEPON	Florianópolis	Santa Catarina
Brazil	Centro Regional Integrado de Oncologia (CRIO)	Fortaleza	Ceará
Brazil	Hospital Haroldo Joaçaba Instituto do Câncer do Ceará	Fortaleza	Ceará
Brazil	Centro de Novos Tratamentos de Itajaí	Itajaí	Santa Catarina
Brazil	Hospital Amaral Carvalho	Jaú	São Paulo
Brazil	CPO - Pucrs	Porto Alegre	Rio Grande do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Hospital Mãe de Deus	Porto Alegre	Rio Grande do Sul
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande do Sul
Brazil	InORP	Ribeirão Preto	São Paulo
Brazil	Centro de Oncologia e Hematologia de Rio Claro	Rio Claro	São Paulo
Brazil	Instituto Nacional do Câncer	Rio de Janeiro
Brazil	Clínica AMO	Salvador	Bahia
Brazil	Clínica CEHON	Salvador	Bahia
Brazil	Núcleo de Oncologia da Bahia - NOB	Salvador	Bahia
Brazil	Centro de Pesquisas em Hematologia e Oncologia	Santo André	Rio Grande do Sul
Brazil	IEP São Lucas	Santo André	São Paulo
Brazil	Hospital AC Camargo	São Paulo
Brazil	Hospital São José	São Paulo
Brazil	ICESP	São Paulo
Brazil	Instituto Brasileiro de Controle do Câncer - IBCC	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Novartis

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

André 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. — View Citation

Autier P, Boniol M, La Vecchia C, Vatten L, Gavin A, Héry 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. Erratum in: BMJ. 2010;341:c4480. LaVecchia, Carlo [corrected to La Vecchia, Carlo].. — View Citation

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. — View Citation

Baselga J, Cortés 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. — View Citation

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, Héniquez 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. — View Citation

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. — View Citation

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. Review. — 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. — View Citation

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. — View Citation

Regierer AC, Wolters R, Ufen MP, Weigel A, Novopashenny I, Köhne 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):633-8. doi: 10.1093/annonc/mdt539. — View Citation

Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Diéras 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. Erratum in: N Engl J Med. 2013 Jun 20;368(25):2442. — View Citation

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. Erratum in: Adv Ther. 2014 Sep;31(9):1008-9. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of sociodemographic and socioeconomics characteristics associated to diagnostic and treatment of metastatic breast cancer in Brazil		8 months
Secondary	Description of demographic characteristics of metastatic breast cancer patients		8 months
Secondary	The clinical and pathological characteristics of patients with metastatic breast cancer		8 months
Secondary	Prior treatment for breast cancer before metastatic disease		8 months
Secondary	The description of the clinical outcome of the patient diagnosed with metastatic breast cancer		8 months
Secondary	Type of treatment after the diagnosis of metastatic breast cancer		8 months