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Completed

NCT Number: NCT05478590

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ambulatorium Chemioterapii Centrum Onkologii, Bydgoszcz, Poland

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns

    Time frame: 01 September 2020 through 31 August 2021

Secondary outcomes

  1. Number of Changes in Clinical Practice During One Year Observational Period in Relation to the Local Breast Cancer (BC) Treatment Guidelines

    Time frame: 01 September 2020 through 31 August 2021

  2. Correlation of Treatment Patterns With the Reference of the si.+-te Defined by Number of Enrolled Patients

    Time frame: 01 September 2020 through 31 August 2021

  3. Demographical Characteristics of Participants

    Time frame: 01 September 2020 through 31 August 2021

  4. Correlation of Treatment Type to Demographical Characteristics of Participants

    Time frame: 01 September 2020 through 31 August 2021

  5. Disease Characteristics of Treated BC Participants

    Time frame: 01 September 2020 through 31 August 2021

  6. Clinical Characteristics of Treated BC Participants

    Time frame: 01 September 2020 through 31 August 2021

  7. Treatment Modalities of Neoadjuvant Therapies Early BC

    Time frame: 01 September 2020 through 31 August 2021

    In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy

  8. Treatment Modalities of Adjuvant Therapies Early BC

    Time frame: 01 September 2020 through 31 August 2021

    In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy

  9. Time to Disease Free Interval

    Time frame: 01 September 2020 through 31 August 2021

    Last Dose of Last Drug Taken in Adjuvant Treatment

  10. Number of Participants With Association Between Disease Characteristic and ABC Treatment Patterns

    Time frame: 01 September 2020 through 31 August 2021

  11. Number of Participants With Association Between Clinical Characteristic and ABC Treatment Patterns

    Time frame: 01 September 2020 through 31 August 2021

  12. Number of Participants With Association Between Neoadjuvant Therapy and ABC Treatment Patterns

    Time frame: 01 September 2020 through 31 August 2021

  13. Number of Participants With Association Between Adjuvant Therapy and ABC Treatment Patterns

    Time frame: 01 September 2020 through 31 August 2021

  14. Number of Participants With Association Between Time to Relapse in early BC Treatment and ABC Treatment Patterns

    Time frame: 01 September 2020 through 31 August 2021

  15. Number of Participants With Association Between Concomitant Therapy and ABC Treatment Patterns

    Time frame: 01 September 2020 through 31 August 2021

  16. Proportion of Participants With Diagnosed Visceral Crisis

    Time frame: 01 September 2020 through 31 August 2021

  17. Number of Visceral Crisis Diagnosis in Compliance With ABC5 Guidelines

    Time frame: 01 September 2020 through 31 August 2021

    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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2022
Registry last updated
Apr 3, 2026

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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