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

Pfizer37 sites in 1 country440 target enrollmentNovember 22, 2021

ConditionsBreast Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Neoplasms
Sponsor: Pfizer
Enrollment: 440
Locations: 37
Primary Endpoint: Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns
Status: Completed
Last Updated: 29 days ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 22, 2021

End Date

September 30, 2022

Last Updated

29 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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

Time Frame: 01 September 2020 through 31 August 2021

Secondary Outcomes

Clinical Characteristics of Treated BC 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)
Demographical Characteristics of Participants(01 September 2020 through 31 August 2021)
Treatment Modalities of Adjuvant Therapies Early BC(01 September 2020 through 31 August 2021)
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)
Time to Disease Free Interval(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 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)
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)
Number of Participants With Association Between Neoadjuvant Therapy and ABC Treatment Patterns(01 September 2020 through 31 August 2021)