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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05034393
Acronym
BRAVE
Enrollment
308
Registered
2021-09-05
Start date
2022-02-04
Completion date
2023-02-27
Last updated
2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Sponsors

Brazilian Breast Cancer Study Group (GBECAM)
CollaboratorUNKNOWN
Latin American Cooperative Oncology Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The proportion of type of first-line treatmentfrom January 2018 to December 2020

Secondary

MeasureTime frame
BC pathological characterizationfrom January 2018 to December 2020
Rate of diagnostic tests to define breast cancer molecular subtypes performedfrom January 2018 to December 2020
The PFS, defined as time from treatment start until progression (by image or physical exam) or deathfrom 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
Patients' demographics characteristicsfrom January 2018 to December 2020
Timeline from first symptom to diagnosisfrom January 2018 to December 2020
Timeline from diagnosis to molecular testfrom January 2018 to December 2020
Timeline from diagnosis to the beginning of treatmentfrom January 2018 to December 2020
Patients' socioeconomic characteristicsfrom 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026