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

NCT ID: NCT05034393

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-04

Study Completion Date

2023-02-27

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brazilian Breast Cancer Study Group (GBECAM)

UNKNOWN

Sponsor Role collaborator

Latin American Cooperative Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gustavo Werutsky

Role: PRINCIPAL_INVESTIGATOR

Latin American Cooperative Oncology Group

Locations

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CINPAM - Centro Integrado de Pesquisa da Amazônia

Manaus, Amazonas, Brazil

Site Status

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Site Status

CLION - Clínica de Oncologia (Oncoclínicas)

Salvador, Estado de Bahia, Brazil

Site Status

Hospital Sírio-Libanês DF

Brasília, Federal District, Brazil

Site Status

IGESDF - Instituto de Gestão Estratégica em Saúde do Distrito Federal

Brasília, Federal District, Brazil

Site Status

Instituto do Câncer Brasil - Unidade Pantanal

Corumbá, Mato Grosso do Sul, Brazil

Site Status

Instituto do Câncer Brasil - Unidade Três Lagoas

Três Lagoas, Mato Grosso do Sul, Brazil

Site Status

Instituto de Hematologia e Oncologia Curitiba (Oncoclínicas)

Curitiba, Paraná, Brazil

Site Status

CPO - Centro Paraibano de Oncologia (Oncoclínicas)

João Pessoa, Paraíba, Brazil

Site Status

HINJA - Hospital Jardim Armália

Volta Redonda, Rio de Janeiro, Brazil

Site Status

CEPESG - Centro de Pesquisa e Educação da Serra Gaúcha

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status

HMV - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto do Câncer Brasil - Unidade Andradina

Andradina, São Paulo, Brazil

Site Status

INCA - Instituto Nacional de Câncer

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LACOG 0221

Identifier Type: -

Identifier Source: org_study_id

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