Clinical trial NCT02662868: Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments
Official title: Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Breast cancer
Metastasis
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2016-01-26
Enrollment: 767
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women \>18 years old, patients diagnosed with metastatic breast cancer in the year of 2012 in Brazil

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

Detailed 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))

Eligibility criteria: 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

Primary outcomes:
measure: Description of sociodemographic and socioeconomics characteristics associated to diagnostic and treatment of metastatic breast cancer in Brazil
timeFrame: 8 months
Secondary outcomes:
measure: Description of demographic characteristics of metastatic breast cancer patients
timeFrame: 8 months
measure: The clinical and pathological characteristics of patients with metastatic breast cancer
timeFrame: 8 months
measure: Prior treatment for breast cancer before metastatic disease
timeFrame: 8 months
measure: The description of the clinical outcome of the patient diagnosed with metastatic breast cancer
timeFrame: 8 months
measure: Type of treatment after the diagnosis of metastatic breast cancer
timeFrame: 8 months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Clínica AMO
state: Bahia
city: Salvador
country: Brazil
facility: Clínica CEHON
state: Bahia
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia - NOB
state: Bahia
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia (CRIO)
state: Ceará
city: Fortaleza
country: Brazil
facility: Hospital Haroldo Joaçaba Instituto do Câncer do Ceará
state: Ceará
city: Brasília
country: Brazil
facility: Oncovida
state: Distrito Federal
city: Bento Gonçalves
country: Brazil
facility: Hospital Tacchini
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: CPO - Pucrs
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: Rio Grande do Sul
city: Santo André
country: Brazil
facility: Centro de Pesquisas em Hematologia e Oncologia
state: Rio Grande do Sul
city: Florianópolis
country: Brazil
facility: Centro de Pesquisas Oncológicas - CEPON
state: Santa Catarina
city: Itajaí
country: Brazil
facility: Centro de Novos Tratamentos de Itajaí
state: Santa Catarina
city: Barretos
country: Brazil
facility: Hospital do Câncer de Barretos
state: São Paulo
city: Jaú
country: Brazil
facility: Hospital Amaral Carvalho
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: InORP
state: São Paulo
city: Rio Claro
country: Brazil
facility: Centro de Oncologia e Hematologia de Rio Claro
state: São Paulo
city: Santo André
country: Brazil
facility: IEP São Lucas
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Câncer
city: São Paulo
country: Brazil
facility: Hospital AC Camargo
city: São Paulo
country: Brazil
facility: Hospital São José
city: São Paulo
country: Brazil
facility: ICESP
city: São Paulo
country: Brazil
facility: Instituto Brasileiro de Controle do Câncer - IBCC
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky, MD
role: STUDY_DIRECTOR
References:
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. Epub 2013 Dec 16.
citation: Autier P, Boniol M, La Vecchia C, Vatten L, Gavin A, Hery 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.
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. Epub 2014 Apr 23.
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.
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.
citation: Regierer AC, Wolters R, Ufen MP, Weigel A, Novopashenny I, Kohne 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):633-638. doi: 10.1093/annonc/mdt539. Epub 2013 Dec 23.
citation: Andre 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. Epub 2014 Feb 3.
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. Epub 2011 Dec 7.
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. Epub 2013 Oct 25.
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, Heniquez 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. Epub 2013 Jun 1.
citation: Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Dieras 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. Epub 2012 Oct 1.
citation: Baselga J, Cortes 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. Epub 2011 Dec 7.