A Study to Describe Treatment Patterns of Advanced Breast Cancer in Poland in the Real-world Data Setting
- Conditions
- Breast Neoplasms
- Registration Number
- NCT05478590
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns 01 September 2020 through 31 August 2021
- Secondary Outcome Measures
Name Time Method Clinical Characteristics of Treated BC Participants 01 September 2020 through 31 August 2021 Demographical Characteristics of Participants 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 Treatment Modalities of Adjuvant Therapies Early BC 01 September 2020 through 31 August 2021 In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy
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 Treatment Modalities of Neoadjuvant Therapies Early BC 01 September 2020 through 31 August 2021 In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy
Time to Disease Free Interval 01 September 2020 through 31 August 2021 Last Dose of Last Drug Taken in Adjuvant Treatment
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 Concomitant 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 Proportion of Participants With Diagnosed Visceral Crisis 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 Visceral Crisis Diagnosis in Compliance With ABC5 Guidelines 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
Correlation of Treatment Type to Demographical Characteristics of Participants 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 Disease Characteristics of Treated BC Participants 01 September 2020 through 31 August 2021
Trial Locations
- Locations (19)
Ambulatorium Chemioterapii Centrum Onkologii
🇵🇱Bydgoszcz, Poland
Wojewodzki Szpital Zespolony w Elblągu - oddzial onkologii
🇵🇱Elblag, Poland
Oddział onkologii Szpital Specjalistyczny im. H. Klimontowicza
🇵🇱Gorlice, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
🇵🇱Gdańsk, Poland
Narodowy Instytut Onkologii
🇵🇱Kraków, Poland
Oddział Onkologii Klinicznej z Pododdziałem Dziennym
🇵🇱Kraków, Poland
Oddział Onkologii Klinicznej
🇵🇱Kalisz, Poland
Opolskie Centrum Onkologii
🇵🇱Opole, Poland
Oddział/Poradnia Onkologiczna Wojewodzki Szpital w Przemyślu
🇵🇱Przemyśl, Poland
Podkarpackie Centrum Onkologii
🇵🇱Rzeszów, Poland
SPZOZ Oddział onkologii klinicznej
🇵🇱Swidnica, Poland
Zachodniopomorskie Centrum Onkologii
🇵🇱Szczecin, Poland
Specjalistyczny Szpital Onkologiczny NU-MED
🇵🇱Tomaszów Mazowiecki, Poland
Izerskie Centrum Pulmonologii i Chemioterapii "Izer-Med" Sp. z o.o
🇵🇱Szklarska Poreba, Poland
Pfizer Polska
🇵🇱Warsaw, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
🇵🇱Warszawa, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
🇵🇱Wroclaw, Poland
Dolnośląskie Centrum Onkologii
🇵🇱Wrocław, Poland
Klinika Onkologii, Instytut Centrum Zdrowia Matki Polki
🇵🇱Łódź, Poland