NCT05034393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

February 4, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

August 27, 2021

Last Update Submit

October 4, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • The proportion of type of first-line treatment

    from January 2018 to December 2020

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen histologically confirmed hormone receptor-positive HER2-negative invasive breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CINPAM - Centro Integrado de Pesquisa da Amazônia

Manaus, Amazonas, 69.020-030, Brazil

Location

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, 60.335-480, Brazil

Location

CLION - Clínica de Oncologia (Oncoclínicas)

Salvador, Estado de Bahia, 40.170-014, Brazil

Location

Hospital Sírio-Libanês DF

Brasília, Federal District, 70.200-730, Brazil

Location

IGESDF - Instituto de Gestão Estratégica em Saúde do Distrito Federal

Brasília, Federal District, 70.335-900, Brazil

Location

Instituto do Câncer Brasil - Unidade Pantanal

Corumbá, Mato Grosso do Sul, 79.332-020, Brazil

Location

Instituto do Câncer Brasil - Unidade Três Lagoas

Três Lagoas, Mato Grosso do Sul, 79.601-001, Brazil

Location

Instituto de Hematologia e Oncologia Curitiba (Oncoclínicas)

Curitiba, Paraná, 82.520-040, Brazil

Location

CPO - Centro Paraibano de Oncologia (Oncoclínicas)

João Pessoa, Paraíba, 58.030-080, Brazil

Location

HINJA - Hospital Jardim Armália

Volta Redonda, Rio de Janeiro, 27.251-260, Brazil

Location

CEPESG - Centro de Pesquisa e Educação da Serra Gaúcha

Caxias do Sul, Rio Grande do Sul, 95.020-450, Brazil

Location

HMV - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90.035-000, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, Brazil

Location

Instituto do Câncer Brasil - Unidade Andradina

Andradina, São Paulo, 16.901-100, Brazil

Location

INCA - Instituto Nacional de Câncer

Rio de Janeiro, 20.230-130, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gustavo Werutsky

    Latin American Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 5, 2021

Study Start

February 4, 2022

Primary Completion

February 27, 2023

Study Completion

February 27, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

BR(15)