Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil
- Conditions
- Breast Cancer
- Registration Number
- NCT05034393
- Lead Sponsor
- Latin American Cooperative Oncology Group
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 308
- 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
- Male Breast Cancer
- First-line treatment for mBC received through clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of type of first-line treatment from January 2018 to December 2020
- Secondary Outcome Measures
Name Time Method 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 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 Timeline from diagnosis to molecular test from January 2018 to December 2020 Rate of diagnostic tests to define breast cancer molecular subtypes performed from January 2018 to December 2020
Trial Locations
- Locations (15)
CPO - Centro Paraibano de Oncologia (Oncoclínicas)
🇧🇷João Pessoa, Paraíba, Brazil
IGESDF - Instituto de Gestão Estratégica em Saúde do Distrito Federal
🇧🇷Brasília, Distrito Federal, Brazil
CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
HINJA - Hospital Jardim Armália
🇧🇷Volta Redonda, Rio De Janeiro, Brazil
INCA - Instituto Nacional de Câncer
🇧🇷Rio De Janeiro, Brazil
CINPAM - Centro Integrado de Pesquisa da Amazônia
🇧🇷Manaus, Amazonas, Brazil
Hospital Sírio-Libanês DF
🇧🇷Brasília, Distrito Federal, Brazil
Instituto do Câncer Brasil - Unidade Pantanal
🇧🇷Corumbá, Mato Grosso Do Sul, Brazil
CLION - Clínica de Oncologia (Oncoclínicas)
🇧🇷Salvador, Bahia, Brazil
Instituto do Câncer Brasil - Unidade Três Lagoas
🇧🇷Três Lagoas, Mato Grosso Do Sul, Brazil
Instituto de Hematologia e Oncologia Curitiba (Oncoclínicas)
🇧🇷Curitiba, Paraná, Brazil
CEPESG - Centro de Pesquisa e Educação da Serra Gaúcha
🇧🇷Caxias Do Sul, Rio Grande Do Sul, Brazil
HMV - Hospital Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Instituto do Câncer Brasil - Unidade Andradina
🇧🇷Andradina, São Paulo, Brazil
CRIO - Centro Regional Integrado de Oncologia
🇧🇷Fortaleza, Ceará, Brazil