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

NCT05478590 | Completed

• 1 other identifier: A5481177
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 19

Brief 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 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.

Conditions

Breast Neoplasms

Keywords

Hormone receptor-positive human epidermal growth factor receptor 2 negative (HR+ HER2-); advanced breast cancer

Outcome Measures

Primary Outcomes (1)

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

  01 September 2020 through 31 August 2021

Secondary Outcomes (17)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

Ambulatorium Chemioterapii Centrum Onkologii

Bydgoszcz, 85-796, Poland

Location

Wojewodzki Szpital Zespolony w Elblągu - oddzial onkologii

Elblag, 82-300, Poland

Location

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, 80-214, Poland

Location

Oddział onkologii Szpital Specjalistyczny im. H. Klimontowicza

Gorlice, 38-300, Poland

Location

Oddział Onkologii Klinicznej

Kalisz, 62-800, Poland

Location

Narodowy Instytut Onkologii

Krakow, 31-115, Poland

Location

Oddział Onkologii Klinicznej z Pododdziałem Dziennym

Krakow, 31-816, Poland

Location

Klinika Onkologii, Instytut Centrum Zdrowia Matki Polki

Lodz, 93-338, Poland

Location

Opolskie Centrum Onkologii

Opole, 45-061, Poland

Location

Oddział/Poradnia Onkologiczna Wojewodzki Szpital w Przemyślu

Przemyśl, 37-700, Poland

Location

Podkarpackie Centrum Onkologii

Rzeszów, 35-055, Poland

Location

SPZOZ Oddział onkologii klinicznej

Swidnica, 58-100, Poland

Location

Zachodniopomorskie Centrum Onkologii

Szczecin, 71-730, Poland

Location

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

Szklarska Poręba, 58-580, Poland

Location

Specjalistyczny Szpital Onkologiczny NU-MED

Tomaszów Mazowiecki, 92-700, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, 02-507, Poland

Location

Pfizer Polska

Warsaw, Poland

Location

Wojewodzki Szpital Specjalistyczny we Wroclawiu

Wroclaw, 51-124, Poland

Location

Dolnośląskie Centrum Onkologii

Wroclaw, 53-413, Poland

Location

Related Publications (1)

• 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.

  PMID: 41438813 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: November 22, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (19)