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Breast NeoplasmsNCT05478590

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

An observational study of Breast Neoplasms, run by Pfizer at 19 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
How many people
440 participants
Where
19 sitesPoland
Study dates
22 Nov 2021to 30 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients treated for the locally advanced/metastatic breast cancer of the HR+ HER2- subtype

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Poland19 sites

  • Ambulatorium Chemioterapii Centrum Onkologii

    Bydgoszcz, 85-796

  • Wojewodzki Szpital Zespolony w Elblągu - oddzial onkologii

    Elblag, 82-300

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-214

  • Oddział onkologii Szpital Specjalistyczny im. H. Klimontowicza

    Gorlice, 38-300

  • Oddział Onkologii Klinicznej

    Kalisz, 62-800

  • Narodowy Instytut Onkologii

    Krakow, 31-115

  • Oddział Onkologii Klinicznej z Pododdziałem Dziennym

    Krakow, 31-816

  • Klinika Onkologii, Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Opolskie Centrum Onkologii

    Opole, 45-061

  • Oddział/Poradnia Onkologiczna Wojewodzki Szpital w Przemyślu

    Przemyśl, 37-700

  • Podkarpackie Centrum Onkologii

    Rzeszów, 35-055

  • SPZOZ Oddział onkologii klinicznej

    Swidnica, 58-100

  • Zachodniopomorskie Centrum Onkologii

    Szczecin, 71-730

  • Izerskie Centrum Pulmonologii i Chemioterapii "Izer-Med" Sp. z o.o

    Szklarska Poręba, 58-580

  • Specjalistyczny Szpital Onkologiczny NU-MED

    Tomaszów Mazowiecki, 92-700

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

  • Pfizer Polska

    Warsaw

  • Wojewodzki Szpital Specjalistyczny we Wroclawiu

    Wroclaw, 51-124

  • Dolnośląskie Centrum Onkologii

    Wroclaw, 53-413

Other trials in Poland

About this study

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

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.

Keywords
Hormone receptor-positive human epidermal growth factor receptor 2 negative (HR+ HER2-), advanced breast cancer
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 01 September 2020 through 31 August 2021

Secondary outcomes (17)

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

    Measured: 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

    Measured: 01 September 2020 through 31 August 2021

  3. Demographical Characteristics of Participants

    Measured: 01 September 2020 through 31 August 2021

  4. Correlation of Treatment Type to Demographical Characteristics of Participants

    Measured: 01 September 2020 through 31 August 2021

  5. Disease Characteristics of Treated BC Participants

    Measured: 01 September 2020 through 31 August 2021

  6. Clinical Characteristics of Treated BC Participants

    Measured: 01 September 2020 through 31 August 2021

  7. Treatment Modalities of Neoadjuvant Therapies Early BC

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

    Measured: 01 September 2020 through 31 August 2021

  8. Treatment Modalities of Adjuvant Therapies Early BC

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

    Measured: 01 September 2020 through 31 August 2021

  9. Time to Disease Free Interval

    Last Dose of Last Drug Taken in Adjuvant Treatment

    Measured: 01 September 2020 through 31 August 2021

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

    Measured: 01 September 2020 through 31 August 2021

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

    Measured: 01 September 2020 through 31 August 2021

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

    Measured: 01 September 2020 through 31 August 2021

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

    Measured: 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

    Measured: 01 September 2020 through 31 August 2021

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

    Measured: 01 September 2020 through 31 August 2021

  16. Proportion of Participants With Diagnosed Visceral Crisis

    Measured: 01 September 2020 through 31 August 2021

  17. 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

    Measured: 01 September 2020 through 31 August 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start22 Nov 2021
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478590
Sponsor's protocol ID
A5481177
Status last verified
Apr 2026
First submitted
26 Jul 2022
Last updated
3 Apr 2026
Results posted
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Radecka B, Zurawski B, Lacko A, Grela-Wojewoda AA, Wieruszewska-Kowalczyk K, Senkus-Konefka E. Real-world treatment patterns of hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer. Contemp Oncol (Pozn). 2025;29(4):370-376. doi: 10.5114/wo.2025.156076. Epub 2025 Nov 11.

    PubMed 41438813

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms, run by Pfizer at 19 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns (time frame: 01 September 2020 through 31 August 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05478590, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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