Clinical trial NCT05478590: A Study to Describe Treatment Patterns of Advanced Breast Cancer in Poland in the Real-world Data Setting
Official title: HR POSITIVE, HER 2 NEGATIVE ADVANCED BREAST CANCER- TREATMENT PATTERNS IN POLAND - HABER STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: Hormone receptor-positive human epidermal growth factor receptor 2 negative (HR+ HER2-)
advanced breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-07-28
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients treated for the locally advanced/metastatic breast cancer of the HR+ HER2- subtype

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns
timeFrame: 01 September 2020 through 31 August 2021
Secondary outcomes:
measure: Number of Changes in Clinical Practice During One Year Observational Period in Relation to the Local Breast Cancer (BC) Treatment Guidelines
timeFrame: 01 September 2020 through 31 August 2021
measure: Correlation of Treatment Patterns With the Reference of the si.+-te Defined by Number of Enrolled Patients
timeFrame: 01 September 2020 through 31 August 2021
measure: Demographical Characteristics of Participants
timeFrame: 01 September 2020 through 31 August 2021
measure: Correlation of Treatment Type to Demographical Characteristics of Participants
timeFrame: 01 September 2020 through 31 August 2021
measure: Disease Characteristics of Treated BC Participants
timeFrame: 01 September 2020 through 31 August 2021
measure: Clinical Characteristics of Treated BC Participants
timeFrame: 01 September 2020 through 31 August 2021
measure: Treatment Modalities of Neoadjuvant Therapies Early BC
timeFrame: 01 September 2020 through 31 August 2021
measure: Treatment Modalities of Adjuvant Therapies Early BC
timeFrame: 01 September 2020 through 31 August 2021
measure: Time to Disease Free Interval
timeFrame: 01 September 2020 through 31 August 2021
measure: Number of Participants With Association Between Disease Characteristic and ABC Treatment Patterns
timeFrame: 01 September 2020 through 31 August 2021
measure: Number of Participants With Association Between Clinical Characteristic and ABC Treatment Patterns
timeFrame: 01 September 2020 through 31 August 2021
measure: Number of Participants With Association Between Neoadjuvant Therapy and ABC Treatment Patterns
timeFrame: 01 September 2020 through 31 August 2021
measure: Number of Participants With Association Between Adjuvant Therapy and ABC Treatment Patterns
timeFrame: 01 September 2020 through 31 August 2021
measure: Number of Participants With Association Between Time to Relapse in early BC Treatment and ABC Treatment Patterns
timeFrame: 01 September 2020 through 31 August 2021
measure: Number of Participants With Association Between Concomitant Therapy and ABC Treatment Patterns
timeFrame: 01 September 2020 through 31 August 2021
measure: Proportion of Participants With Diagnosed Visceral Crisis
timeFrame: 01 September 2020 through 31 August 2021
measure: Number of Visceral Crisis Diagnosis in Compliance With ABC5 Guidelines
timeFrame: 01 September 2020 through 31 August 2021
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Ambulatorium Chemioterapii Centrum Onkologii
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony w Elblągu - oddzial onkologii
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Gorlice
country: Poland
facility: Oddział onkologii Szpital Specjalistyczny im. H. Klimontowicza
city: Kalisz
country: Poland
facility: Oddział Onkologii Klinicznej
city: Kraków
country: Poland
facility: Narodowy Instytut Onkologii
city: Kraków
country: Poland
facility: Oddział Onkologii Klinicznej z Pododdziałem Dziennym
city: Opole
country: Poland
facility: Opolskie Centrum Onkologii
city: Przemyśl
country: Poland
facility: Oddział/Poradnia Onkologiczna Wojewodzki Szpital w Przemyślu
city: Rzeszów
country: Poland
facility: Podkarpackie Centrum Onkologii
city: Swidnica
country: Poland
facility: SPZOZ Oddział onkologii klinicznej
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii
city: Szklarska Poreba
country: Poland
facility: Izerskie Centrum Pulmonologii i Chemioterapii "Izer-Med" Sp. z o.o
city: Tomaszów Mazowiecki
country: Poland
facility: Specjalistyczny Szpital Onkologiczny NU-MED
city: Warsaw
country: Poland
facility: Pfizer Polska
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSWiA w Warszawie
city: Wroclaw
country: Poland
facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu
city: Wrocław
country: Poland
facility: Dolnośląskie Centrum Onkologii
city: Łódź
country: Poland
facility: Klinika Onkologii, Instytut Centrum Zdrowia Matki Polki
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: