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OpenTrials
Completed

NCT Number: NCT05034393

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CINPAM - Centro Integrado de Pesquisa da Amazônia, Manaus, Amazonas, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The proportion of type of first-line treatment

    Time frame: from January 2018 to December 2020

Secondary outcomes

  1. 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

  2. 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

  3. The PFS will be evaluated by type of health care coverage (public vs private).

    Time frame: from January 2018 to December 2020

  4. Timeline from first symptom to diagnosis

    Time frame: from January 2018 to December 2020

  5. Timeline from diagnosis to molecular test

    Time frame: from January 2018 to December 2020

  6. Timeline from diagnosis to the beginning of treatment

    Time frame: from January 2018 to December 2020

  7. Patients' socioeconomic characteristics

    Time frame: from January 2018 to December 2020

  8. Patients' demographics characteristics

    Time frame: from January 2018 to December 2020

  9. BC pathological characterization

    Time frame: from January 2018 to December 2020

  10. Rate of diagnostic tests to define breast cancer molecular subtypes performed

    Time frame: from January 2018 to December 2020

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

  • Brazilian Breast Cancer Study Group (GBECAM)

Registry information

Acronym: BRAVE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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