A Study to Describe Treatment Patterns of Advanced Breast Cancer in Poland in the Real-world Data Setting

Study Overview
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Brief Summary
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The study is descriptive and aims to characterize the treatment patterns of advanced breast cancer in Poland in the real-world data setting. The main goals are to assess the current treatment patterns of hormone receptor-positive (HR+) Human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer and their changes in clinical practice and relate them to patients' demographics, disease characteristics, type of other therapies used in patients as well as disease progression and visceral crisis occurrence.

Official Title
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HR POSITIVE, HER 2 NEGATIVE ADVANCED BREAST CANCER- TREATMENT PATTERNS IN POLAND - HABER STUDY

Conditions
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Breast Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with histologically diagnosed advanced breast cancer (with locoregional recurrence not eligible for radical local treatment or with distant metastases) Patient has a documented hormone (estrogen and/or progesterone) receptor expression and lack of HER2 receptor overexpression or lack of HER2 gene amplification (HR+/HER2- breast cancer subtype) Patient had no prior treatment for advanced breast cancer Patient has no symptomatic metastases to the central nervous system There is no other malignancies in patient requiring active treatment Patient is without co-occurring other malignancies treated with palliative assumption Exclusion Criteria: Parallel patient's participation in any other clinical trial at the time when the decision over the advanced breast cancer treatment was made or up to 30 days before it.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns |  | 01 September 2020 through 31 August 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Changes in Clinical Practice During One Year Observational Period in Relation to the Local Breast Cancer (BC) Treatment Guidelines |  | 01 September 2020 through 31 August 2021 | 
| Correlation of Treatment Patterns With the Reference of the si.+-te Defined by Number of Enrolled Patients |  | 01 September 2020 through 31 August 2021 | 
| Demographical Characteristics of Participants |  | 01 September 2020 through 31 August 2021 | 
| Correlation of Treatment Type to Demographical Characteristics of Participants |  | 01 September 2020 through 31 August 2021 | 
| Disease Characteristics of Treated BC Participants |  | 01 September 2020 through 31 August 2021 | 
| Clinical Characteristics of Treated BC Participants |  | 01 September 2020 through 31 August 2021 | 
| Treatment Modalities of Neoadjuvant Therapies Early BC | In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy | 01 September 2020 through 31 August 2021 | 
| Treatment Modalities of Adjuvant Therapies Early BC | In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy | 01 September 2020 through 31 August 2021 | 
| Time to Disease Free Interval | Last Dose of Last Drug Taken in Adjuvant Treatment | 01 September 2020 through 31 August 2021 | 
| Number of Participants With Association Between Disease Characteristic and ABC Treatment Patterns |  | 01 September 2020 through 31 August 2021 | 
| Number of Participants With Association Between Clinical Characteristic and ABC Treatment Patterns |  | 01 September 2020 through 31 August 2021 | 
| Number of Participants With Association Between Neoadjuvant Therapy and ABC Treatment Patterns |  | 01 September 2020 through 31 August 2021 | 
| Number of Participants With Association Between Adjuvant Therapy and ABC Treatment Patterns |  | 01 September 2020 through 31 August 2021 | 
| Number of Participants With Association Between Time to Relapse in early BC Treatment and ABC Treatment Patterns |  | 01 September 2020 through 31 August 2021 | 
| Number of Participants With Association Between Concomitant Therapy and ABC Treatment Patterns |  | 01 September 2020 through 31 August 2021 | 
| Proportion of Participants With Diagnosed Visceral Crisis |  | 01 September 2020 through 31 August 2021 | 
| Number of Visceral Crisis Diagnosis in Compliance With ABC5 Guidelines | ABC5 guideline definition visceral crisis (updated in 2020) is a severe organ disfunction that involve: Severe symptoms and signs, rapid disease progression, and laboratory values | 01 September 2020 through 31 August 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone receptor-positive human epidermal growth factor receptor 2 negative (HR+ HER2-), advanced breast cancer