Clinical trial NCT05034393: Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil
Official title: Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Brazilian Breast Cancer Study Group (GBECAM)
First posted: 2021-09-05
Enrollment: 308
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of type of first-line treatment
timeFrame: from January 2018 to December 2020
Secondary outcomes:
measure: The PFS, defined as time from treatment start until progression (by image or physical exam) or death
timeFrame: from January 2018 to December 2020
measure: First-line treatment according to the drug name by type of health care coverage (public vs private)
timeFrame: from January 2018 to December 2020
measure: The PFS will be evaluated by type of health care coverage (public vs private).
timeFrame: from January 2018 to December 2020
measure: Timeline from first symptom to diagnosis
timeFrame: from January 2018 to December 2020
measure: Timeline from diagnosis to molecular test
timeFrame: from January 2018 to December 2020
measure: Timeline from diagnosis to the beginning of treatment
timeFrame: from January 2018 to December 2020
measure: Patients' socioeconomic characteristics
timeFrame: from January 2018 to December 2020
measure: Patients' demographics characteristics
timeFrame: from January 2018 to December 2020
measure: BC pathological characterization
timeFrame: from January 2018 to December 2020
measure: Rate of diagnostic tests to define breast cancer molecular subtypes performed
timeFrame: from January 2018 to December 2020
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: CINPAM - Centro Integrado de Pesquisa da Amazônia
state: Amazonas
city: Salvador
country: Brazil
facility: CLION - Clínica de Oncologia (Oncoclínicas)
state: Bahia
city: Fortaleza
country: Brazil
facility: CRIO - Centro Regional Integrado de Oncologia
state: Ceará
city: Brasília
country: Brazil
facility: Hospital Sírio-Libanês DF
state: Distrito Federal
city: Brasília
country: Brazil
facility: IGESDF - Instituto de Gestão Estratégica em Saúde do Distrito Federal
state: Distrito Federal
city: Corumbá
country: Brazil
facility: Instituto do Câncer Brasil - Unidade Pantanal
state: Mato Grosso Do Sul
city: Três Lagoas
country: Brazil
facility: Instituto do Câncer Brasil - Unidade Três Lagoas
state: Mato Grosso Do Sul
city: Curitiba
country: Brazil
facility: Instituto de Hematologia e Oncologia Curitiba (Oncoclínicas)
state: Paraná
city: João Pessoa
country: Brazil
facility: CPO - Centro Paraibano de Oncologia (Oncoclínicas)
state: Paraíba
city: Volta Redonda
country: Brazil
facility: HINJA - Hospital Jardim Armália
state: Rio De Janeiro
city: Caxias Do Sul
country: Brazil
facility: CEPESG - Centro de Pesquisa e Educação da Serra Gaúcha
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: HMV - Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Andradina
country: Brazil
facility: Instituto do Câncer Brasil - Unidade Andradina
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: INCA - Instituto Nacional de Câncer
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky
role: PRINCIPAL_INVESTIGATOR
References: