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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms

• Study Type: Observational
• Enrollment (Actual): 440

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland, 85-796
    • Ambulatorium Chemioterapii Centrum Onkologii
  • Elblag, Poland, 82-300
    • Wojewodzki Szpital Zespolony w Elblągu - oddzial onkologii
  • Gdańsk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
  • Gorlice, Poland, 38-300
    • Oddział onkologii Szpital Specjalistyczny im. H. Klimontowicza
  • Kalisz, Poland, 62-800
    • Oddział Onkologii Klinicznej
  • Kraków, Poland, 31-115
    • Narodowy Instytut Onkologii
  • Kraków, Poland, 31-816
    • Oddział Onkologii Klinicznej z Pododdziałem Dziennym
  • Opole, Poland, 45-061
    • Opolskie Centrum Onkologii
  • Przemyśl, Poland, 37-700
    • Oddział/Poradnia Onkologiczna Wojewodzki Szpital w Przemyślu
  • Rzeszów, Poland, 35-055
    • Podkarpackie Centrum Onkologii
  • Swidnica, Poland, 58-100
    • SPZOZ Oddział onkologii klinicznej
  • Szczecin, Poland, 71-730
    • Zachodniopomorskie Centrum Onkologii
  • Szklarska Poreba, Poland, 58-580
    • Izerskie Centrum Pulmonologii i Chemioterapii "Izer-Med" Sp. z o.o
  • Tomaszów Mazowiecki, Poland, 92-700
    • Specjalistyczny Szpital Onkologiczny NU-MED
  • Warsaw, Poland
    • Pfizer Polska
  • Warszawa, Poland, 02-507
    • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Wroclaw, Poland, 51-124
    • Wojewodzki Szpital Specjalistyczny We Wroclawiu
  • Wrocław, Poland, 53-413
    • Dolnoslaskie Centrum Onkologii
  • Łódź, Poland, 93-338
    • Klinika Onkologii, Instytut Centrum Zdrowia Matki Polki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns	01 September 2020 through 31 August 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Clinical Characteristics of Treated BC Participants		01 September 2020 through 31 August 2021
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
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
Time to Disease Free Interval	Last Dose of Last Drug Taken in Adjuvant Treatment	01 September 2020 through 31 August 2021
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 Neoadjuvant Therapy and ABC Treatment Patterns		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 Participants With Association Between Time to Relapse in early BC Treatment 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
Proportion of Participants With Diagnosed Visceral Crisis		01 September 2020 through 31 August 2021
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: advanced breast cancer; Hormone receptor-positive human epidermal growth factor receptor 2 negative (HR+ HER2-)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: A5481177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.