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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05478590
• Other study ID #: A5481177
• Status: Completed
• Start date: November 22, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Poland	Ambulatorium Chemioterapii Centrum Onkologii	Bydgoszcz
Poland	Wojewodzki Szpital Zespolony w Elblagu - oddzial onkologii	Elblag
Poland	Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii	Gdansk
Poland	Oddzial onkologii Szpital Specjalistyczny im. H. Klimontowicza	Gorlice
Poland	Oddzial Onkologii Klinicznej	Kalisz
Poland	Narodowy Instytut Onkologii	Kraków
Poland	Oddzial Onkologii Klinicznej z Pododdzialem Dziennym	Kraków
Poland	Klinika Onkologii, Instytut Centrum Zdrowia Matki Polki	Lódz
Poland	Opolskie Centrum Onkologii	Opole
Poland	Oddzial/Poradnia Onkologiczna Wojewodzki Szpital w Przemyslu	Przemysl
Poland	Podkarpackie Centrum Onkologii	Rzeszów
Poland	SPZOZ Oddzial onkologii klinicznej	Swidnica
Poland	Zachodniopomorskie Centrum Onkologii	Szczecin
Poland	Izerskie Centrum Pulmonologii i Chemioterapii "Izer-Med" Sp. z o.o	Szklarska Poreba
Poland	Specjalistyczny Szpital Onkologiczny NU-MED	Tomaszów Mazowiecki
Poland	Pfizer Polska	Warsaw
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warszawa
Poland	Dolnoslaskie Centrum Onkologii	Wroclaw
Poland	Wojewodzki Szpital Specjalistyczny we Wroclawiu	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns		01 September 2020 through 31 August 2021
Secondary	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
Secondary	Correlation of Treatment Patterns With the Reference of the si.+-te Defined by Number of Enrolled Patients		01 September 2020 through 31 August 2021
Secondary	Demographical Characteristics of Participants		01 September 2020 through 31 August 2021
Secondary	Correlation of Treatment Type to Demographical Characteristics of Participants		01 September 2020 through 31 August 2021
Secondary	Disease Characteristics of Treated BC Participants		01 September 2020 through 31 August 2021
Secondary	Clinical Characteristics of Treated BC Participants		01 September 2020 through 31 August 2021
Secondary	Treatment Modalities of Neoadjuvant Therapies Early BC	In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy	01 September 2020 through 31 August 2021
Secondary	Treatment Modalities of Adjuvant Therapies Early BC	In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy	01 September 2020 through 31 August 2021
Secondary	Time to Disease Free Interval	Last Dose of Last Drug Taken in Adjuvant Treatment	01 September 2020 through 31 August 2021
Secondary	Number of Participants With Association Between Disease Characteristic and ABC Treatment Patterns		01 September 2020 through 31 August 2021
Secondary	Number of Participants With Association Between Clinical Characteristic and ABC Treatment Patterns		01 September 2020 through 31 August 2021
Secondary	Number of Participants With Association Between Neoadjuvant Therapy and ABC Treatment Patterns		01 September 2020 through 31 August 2021
Secondary	Number of Participants With Association Between Adjuvant Therapy and ABC Treatment Patterns		01 September 2020 through 31 August 2021
Secondary	Number of Participants With Association Between Time to Relapse in early BC Treatment and ABC Treatment Patterns		01 September 2020 through 31 August 2021
Secondary	Number of Participants With Association Between Concomitant Therapy and ABC Treatment Patterns		01 September 2020 through 31 August 2021
Secondary	Proportion of Participants With Diagnosed Visceral Crisis		01 September 2020 through 31 August 2021
Secondary	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	01 September 2020 through 31 August 2021

External Links

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