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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with de novo or recurrent HR-positive HER2-negative mBC<br>Patients diagnosed with de novo or recurrent HR-positive HER2-negative mBC from January 2018 to December 2020 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of type of first-line treatment |  | from January 2018 to December 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Timeline from diagnosis to the beginning of treatment |  | from January 2018 to December 2020 | 
| Patients' socioeconomic characteristics |  | from January 2018 to December 2020 | 
| Patients' demographics characteristics |  | from January 2018 to December 2020 | 
| BC pathological characterization |  | from January 2018 to December 2020 | 
| Rate of diagnostic tests to define breast cancer molecular subtypes performed |  | from January 2018 to December 2020 |