Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil (BRAVE)

This study aims to describe in detail the patient journey from diagnosis to the beginning of treatment and patterns of care of hormone receptor- positive, HER2-negative de novo or recurrent metastatic breast cancer between January 2018 and December 2020 in Brazil.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 308

Contacts and Locations

• Study Contact: Name: Gustavo Werutsky, MD; Phone Number: +55 51 33723835; Email: gustavo.werutsky@lacogcancerresearch.org
• Study Contact Backup: Name: Latin American Cooperative Oncology Group (LACOG); Phone Number: +55 51 3384 5334

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 20.230-130
    • INCA - Instituto Nacional de Cancer
  • Amazonas
    • Manaus, Amazonas, Brazil, 69.020-030
      • CINPAM - Centro Integrado de Pesquisa da Amazônia
  • Bahia
    • Salvador, Bahia, Brazil, 40.170-014
      • CLION - Clínica de Oncologia (Oncoclínicas)
  • Ceará
    • Fortaleza, Ceará, Brazil, 60.335-480
      • Crio - Centro Regional Integrado de Oncologia
  • Distrito Federal
    • Brasília, Distrito Federal, Brazil, 70.200-730
      • Hospital Sírio-Libanês DF
    • Brasília, Distrito Federal, Brazil, 70.335-900
      • IGESDF - Instituto de Gestão Estratégica em Saúde do Distrito Federal
  • Mato Grosso Do Sul
    • Corumbá, Mato Grosso Do Sul, Brazil, 79.332-020
      • Instituto do Câncer Brasil - Unidade Pantanal
    • Três Lagoas, Mato Grosso Do Sul, Brazil, 79.601-001
      • Instituto do Câncer Brasil - Unidade Três Lagoas
  • Paraná
    • Curitiba, Paraná, Brazil, 82.520-040
      • Instituto de Hematologia e Oncologia Curitiba (Oncoclínicas)
  • Paraíba
    • João Pessoa, Paraíba, Brazil, 58.030-080
      • CPO - Centro Paraibano de Oncologia (Oncoclínicas)
  • Rio De Janeiro
    • Volta Redonda, Rio De Janeiro, Brazil, 27.251-260
      • HINJA - Hospital Jardim Armália
  • Rio Grande Do Sul
    • Caxias Do Sul, Rio Grande Do Sul, Brazil, 95.020-450
      • CEPESG - Centro de Pesquisa e Educação da Serra Gaúcha
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90.035-000
      • HMV - Hospital Moinhos de Vento
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
  • São Paulo
    • Andradina, São Paulo, Brazil, 16.901-100
      • Instituto do Câncer Brasil - Unidade Andradina

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study will be performed in up to 15 sites in Brazil so that the recruitment target is reached within defined milestones. An adequate geographical distribution of sites within Brazil will be pursued to strengthen representation of Brazilian population. Considering the incidence of mBC.

Description

Inclusion Criteria:

• Women ≥18 years old
• Histologically confirmed hormone receptor-positive HER2-negative invasive breast cancer
• Hormone receptor-positive defined as 1% to 100% of tumor nuclei positive for Estrogen - - Receptor and/or Progesterone Receptor, as per ASCO/CAP Guideline 2020 - or Allred score of ≥3
• HER2-negative defined as IHC result is 0/1+ or 2+ with ISH negative as per ASCO/CAP Guideline 2018
• Diagnosed with de novo or recurrent metastatic breast cancer between January 2018 -and December 2020
• Public health system or private health system

Exclusion Criteria:

• Male Breast Cancer
• First-line treatment for mBC received through clinical trial

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with de novo or recurrent HR-positive HER2-negative mBC; Patients diagnosed with de novo or recurrent HR-positive HER2-negative mBC from January 2018 to December 2020

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of type of first-line treatment	from January 2018 to December 2020

Secondary Outcome Measures

Outcome Measure	Time Frame
The PFS, defined as time from treatment start until progression (by image or physical exam) or death	from January 2018 to December 2020
First-line treatment according to the drug name by type of health care coverage (public vs private)	from January 2018 to December 2020
The PFS will be evaluated by type of health care coverage (public vs private).	from January 2018 to December 2020
Timeline from first symptom to diagnosis	from January 2018 to December 2020
Timeline from diagnosis to molecular test	from January 2018 to December 2020
Timeline from diagnosis to the beginning of treatment	from January 2018 to December 2020
Patients' socioeconomic characteristics	from January 2018 to December 2020
Patients' demographics characteristics	from January 2018 to December 2020
BC pathological characterization	from January 2018 to December 2020
Rate of diagnostic tests to define breast cancer molecular subtypes performed	from January 2018 to December 2020

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Collaborators: Brazilian Breast Cancer Study Group (GBECAM)
• Investigators: Principal Investigator: Gustavo Werutsky, Latin American Cooperative Oncology Group

Publications and helpful links

General Publications

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
• Howlader N, Cronin KA, Kurian AW, Andridge R. Differences in Breast Cancer Survival by Molecular Subtypes in the United States. Cancer Epidemiol Biomarkers Prev. 2018 Jun;27(6):619-626. doi: 10.1158/1055-9965.EPI-17-0627. Epub 2018 Mar 28.
• Heer E, Harper A, Escandor N, Sung H, McCormack V, Fidler-Benaoudia MM. Global burden and trends in premenopausal and postmenopausal breast cancer: a population-based study. Lancet Glob Health. 2020 Aug;8(8):e1027-e1037. doi: 10.1016/S2214-109X(20)30215-1.
• 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.
• Deluche E, Antoine A, Bachelot T, Lardy-Cleaud A, Dieras V, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Courtinard C, Perol D, Robain M, Delaloge S. Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008-2016. Eur J Cancer. 2020 Apr;129:60-70. doi: 10.1016/j.ejca.2020.01.016. Epub 2020 Mar 2.
• Rosa DD, Bines J, Werutsky G, Barrios CH, Cronemberger E, Queiroz GS, de Lima VCC, Freitas-Junior R, Couto JD, Emerenciano K, Resende H, Crocamo S, Reinert T, Van Eyil B, Neron Y, Dybal V, Lazaretti N, de Cassia Costamilan R, de Andrade DAP, Mathias C, Vacaro GZ, Borges G, Morelle A, Caleffi M, Filho CS, Mano MS, Zaffaroni F, de Jesus RG, Simon SD. The impact of sociodemographic factors and health insurance coverage in the diagnosis and clinicopathological characteristics of breast cancer in Brazil: AMAZONA III study (GBECAM 0115). Breast Cancer Res Treat. 2020 Oct;183(3):749-757. doi: 10.1007/s10549-020-05831-y. Epub 2020 Jul 29.
• Harbeck N, Penault-Llorca F, Cortes J, Gnant M, Houssami N, Poortmans P, Ruddy K, Tsang J, Cardoso F. Breast cancer. Nat Rev Dis Primers. 2019 Sep 23;5(1):66. doi: 10.1038/s41572-019-0111-2.
• Waks AG, Winer EP. Breast Cancer Treatment: A Review. JAMA. 2019 Jan 22;321(3):288-300. doi: 10.1001/jama.2018.19323.
• 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.
• Torre LA, Islami F, Siegel RL, Ward EM, Jemal A. Global Cancer in Women: Burden and Trends. Cancer Epidemiol Biomarkers Prev. 2017 Apr;26(4):444-457. doi: 10.1158/1055-9965.EPI-16-0858. Epub 2017 Feb 21.
• Cardoso F, Paluch-Shimon S, Senkus E, Curigliano G, Aapro MS, Andre F, Barrios CH, Bergh J, Bhattacharyya GS, Biganzoli L, Boyle F, Cardoso MJ, Carey LA, Cortes J, El Saghir NS, Elzayat M, Eniu A, Fallowfield L, Francis PA, Gelmon K, Gligorov J, Haidinger R, Harbeck N, Hu X, Kaufman B, Kaur R, Kiely BE, Kim SB, Lin NU, Mertz SA, Neciosup S, Offersen BV, Ohno S, Pagani O, Prat A, Penault-Llorca F, Rugo HS, Sledge GW, Thomssen C, Vorobiof DA, Wiseman T, Xu B, Norton L, Costa A, Winer EP. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020 Dec;31(12):1623-1649. doi: 10.1016/j.annonc.2020.09.010. Epub 2020 Sep 23. No abstract available.
• Public Policy Committee, International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practice (GPP). Pharmacoepidemiol Drug Saf. 2016 Jan;25(1):2-10. doi: 10.1002/pds.3891. Epub 2015 Nov 5. No abstract available.
• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007 Oct 16;147(8):573-7. doi: 10.7326/0003-4819-147-8-200710160-00010. Erratum In: Ann Intern Med. 2008 Jan 15;148(2):168.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LACOG 0221

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No