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

Breast Cancer Clinical Trial

— BRAVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034393
• Other study ID #: LACOG 0221
• Status: Completed
• Start date: February 4, 2022
• Est. completion date: February 27, 2023

Study information

• Verified date: October 2023
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Brazil	Instituto do Câncer Brasil - Unidade Andradina	Andradina	São Paulo
Brazil	Hospital Sírio-Libanês DF	Brasília	Distrito Federal
Brazil	IGESDF - Instituto de Gestão Estratégica em Saúde do Distrito Federal	Brasília	Distrito Federal
Brazil	CEPESG - Centro de Pesquisa e Educação da Serra Gaúcha	Caxias Do Sul	Rio Grande Do Sul
Brazil	Instituto do Câncer Brasil - Unidade Pantanal	Corumbá	Mato Grosso Do Sul
Brazil	Instituto de Hematologia e Oncologia Curitiba (Oncoclínicas)	Curitiba	Paraná
Brazil	CRIO - Centro Regional Integrado de Oncologia	Fortaleza	Ceará
Brazil	CPO - Centro Paraibano de Oncologia (Oncoclínicas)	João Pessoa	Paraíba
Brazil	CINPAM - Centro Integrado de Pesquisa da Amazônia	Manaus	Amazonas
Brazil	CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS	Porto Alegre	Rio Grande Do Sul
Brazil	HMV - Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	INCA - Instituto Nacional de Câncer	Rio De Janeiro
Brazil	CLION - Clínica de Oncologia (Oncoclínicas)	Salvador	Bahia
Brazil	Instituto do Câncer Brasil - Unidade Três Lagoas	Três Lagoas	Mato Grosso Do Sul
Brazil	HINJA - Hospital Jardim Armália	Volta Redonda	Rio De Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Brazilian Breast Cancer Study Group (GBECAM)

Country where clinical trial is conducted

Brazil, 

Outcome

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