Breast CancerBRAVENCT05034393
Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil
An observational study of Breast Cancer, run by Latin American Cooperative Oncology Group at 15 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 308 participants
- Where
- 15 sitesBrazil
- Study dates
- 4 Feb 2022to 27 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Male Breast Cancer
- First-line treatment for mBC received through clinical trial
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Brazil15 sites
Instituto do Câncer Brasil - Unidade Andradina
Andradina, São Paulo, 16.901-100
Hospital Sírio-Libanês DF
Brasília, Federal District, 70.200-730
IGESDF - Instituto de Gestão Estratégica em Saúde do Distrito Federal
Brasília, Federal District, 70.335-900
CEPESG - Centro de Pesquisa e Educação da Serra Gaúcha
Caxias do Sul, Rio Grande do Sul, 95.020-450
Instituto do Câncer Brasil - Unidade Pantanal
Corumbá, Mato Grosso do Sul, 79.332-020
Instituto de Hematologia e Oncologia Curitiba (Oncoclínicas)
Curitiba, Paraná, 82.520-040
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60.335-480
CPO - Centro Paraibano de Oncologia (Oncoclínicas)
João Pessoa, Paraíba, 58.030-080
CINPAM - Centro Integrado de Pesquisa da Amazônia
Manaus, Amazonas, 69.020-030
HMV - Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90.035-000
CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul
INCA - Instituto Nacional de Câncer
Rio de Janeiro, 20.230-130
CLION - Clínica de Oncologia (Oncoclínicas)
Salvador, Estado de Bahia, 40.170-014
Instituto do Câncer Brasil - Unidade Três Lagoas
Três Lagoas, Mato Grosso do Sul, 79.601-001
HINJA - Hospital Jardim Armália
Volta Redonda, Rio de Janeiro, 27.251-260
About this study
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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The proportion of type of first-line treatment
Measured: 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
Measured: from January 2018 to December 2020
First-line treatment according to the drug name by type of health care coverage (public vs private)
Measured: from January 2018 to December 2020
The PFS will be evaluated by type of health care coverage (public vs private).
Measured: from January 2018 to December 2020
Timeline from first symptom to diagnosis
Measured: from January 2018 to December 2020
Timeline from diagnosis to molecular test
Measured: from January 2018 to December 2020
Timeline from diagnosis to the beginning of treatment
Measured: from January 2018 to December 2020
Patients' socioeconomic characteristics
Measured: from January 2018 to December 2020
Patients' demographics characteristics
Measured: from January 2018 to December 2020
BC pathological characterization
Measured: from January 2018 to December 2020
Rate of diagnostic tests to define breast cancer molecular subtypes performed
Measured: from January 2018 to December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start4 Feb 2022
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Brazilian Breast Cancer Study Group (GBECAM)
- Responsible party
- Sponsor
- Investigators
- Gustavo Werutsky, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034393
- Sponsor's protocol ID
- LACOG 0221
- Acronym
- BRAVE
- Status last verified
- Oct 2023
- First submitted
- 27 Aug 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil
- ClinicalTrials.gov ID
- NCT05034393
- Acronym / sponsor ID
- BRAVE / LACOG 0221
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Brazilian Breast Cancer Study Group (GBECAM)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Male Breast Cancer
- First-line treatment for mBC received through clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of type of first-line treatment
Time frame: from January 2018 to December 2020
10 secondary outcomes
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
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
The PFS will be evaluated by type of health care coverage (public vs private).
Time frame: from January 2018 to December 2020
Timeline from first symptom to diagnosis
Time frame: from January 2018 to December 2020
Timeline from diagnosis to molecular test
Time frame: from January 2018 to December 2020
Timeline from diagnosis to the beginning of treatment
Time frame: from January 2018 to December 2020
Patients' socioeconomic characteristics
Time frame: from January 2018 to December 2020
Patients' demographics characteristics
Time frame: from January 2018 to December 2020
BC pathological characterization
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Werutsky principal investigator
Latin American Cooperative Oncology Group
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Latin American Cooperative Oncology Group at 15 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of type of first-line treatment (time frame: from January 2018 to December 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.