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

October 4, 2023 updated by: Latin American Cooperative Oncology Group
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Latin American Cooperative Oncology Group (LACOG)
  • Phone Number: +55 51 3384 5334

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 20.230-130
        • INCA - Instituto Nacional de Câncer
    • Amazonas
      • Manaus, Amazonas, Brazil, 69.020-030
        • CINPAM - Centro Integrado de Pesquisa da Amazônia
    • Bahia
      • Salvador, Bahia, Brazil, 40.170-014
        • CLION - Clínica de Oncologia (Oncoclínicas)
    • Ceará
      • Fortaleza, Ceará, Brazil, 60.335-480
        • CRIO - Centro Regional Integrado de Oncologia
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 70.200-730
        • Hospital Sírio-Libanês DF
      • Brasília, Distrito Federal, Brazil, 70.335-900
        • IGESDF - Instituto de Gestão Estratégica em Saúde do Distrito Federal
    • Mato Grosso Do Sul
      • Corumbá, Mato Grosso Do Sul, Brazil, 79.332-020
        • Instituto do Câncer Brasil - Unidade Pantanal
      • Três Lagoas, Mato Grosso Do Sul, Brazil, 79.601-001
        • Instituto do Câncer Brasil - Unidade Três Lagoas
    • Paraná
      • Curitiba, Paraná, Brazil, 82.520-040
        • Instituto de Hematologia e Oncologia Curitiba (Oncoclínicas)
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58.030-080
        • CPO - Centro Paraibano de Oncologia (Oncoclínicas)
    • Rio De Janeiro
      • Volta Redonda, Rio De Janeiro, Brazil, 27.251-260
        • HINJA - Hospital Jardim Armália
    • Rio Grande Do Sul
      • Caxias Do Sul, Rio Grande Do Sul, Brazil, 95.020-450
        • CEPESG - Centro de Pesquisa e Educação da Serra Gaúcha
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.035-000
        • HMV - Hospital Moinhos de Vento
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
    • São Paulo
      • Andradina, São Paulo, Brazil, 16.901-100
        • Instituto do Câncer Brasil - Unidade Andradina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The proportion of type of first-line treatment
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The PFS, defined as time from treatment start until progression (by image or physical exam) or death
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020
First-line treatment according to the drug name by type of health care coverage (public vs private)
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020
The PFS will be evaluated by type of health care coverage (public vs private).
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020
Timeline from first symptom to diagnosis
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020
Timeline from diagnosis to molecular test
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020
Timeline from diagnosis to the beginning of treatment
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020
Patients' socioeconomic characteristics
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020
Patients' demographics characteristics
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020
BC pathological characterization
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020
Rate of diagnostic tests to define breast cancer molecular subtypes performed
Time Frame: from January 2018 to December 2020
from January 2018 to December 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Latin American Cooperative Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brazilian Breast Cancer Study Group (GBECAM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gustavo Werutsky, Latin American Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LACOG 0221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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