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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05478590
Recruitment Status : Recruiting
First Posted : July 28, 2022
Last Update Posted : July 28, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease
Breast Neoplasms

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: HR Positive, HER 2 Negative Advanced Breast Cancer- trEatment patteRns in Poland - HABER Study
Actual Study Start Date : November 22, 2021
Estimated Primary Completion Date : December 2, 2022
Estimated Study Completion Date : December 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns [ Time Frame: 01 September 2020 through 31 August 2021 ]

Secondary Outcome Measures :
  1. Number of Changes in Clinical Practice During One Year Observational Period in Relation to the Local Breast Cancer (BC) Treatment Guidelines [ Time Frame: 01 September 2020 through 31 August 2021 ]
  2. Correlation of Treatment Patterns With the Reference of the si.+-te Defined by Number of Enrolled Patients [ Time Frame: 01 September 2020 through 31 August 2021 ]
  3. Demographical Characteristics of Participants [ Time Frame: 01 September 2020 through 31 August 2021 ]
  4. Correlation of Treatment Type to Demographical Characteristics of Participants [ Time Frame: 01 September 2020 through 31 August 2021 ]
  5. Disease Characteristics of Treated BC Participants [ Time Frame: 01 September 2020 through 31 August 2021 ]
  6. Clinical Characteristics of Treated BC Participants [ Time Frame: 01 September 2020 through 31 August 2021 ]
  7. Treatment Modalities of Neoadjuvant Therapies Early BC [ Time Frame: 01 September 2020 through 31 August 2021 ]
    In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy

  8. Treatment Modalities of Adjuvant Therapies Early BC [ Time Frame: 01 September 2020 through 31 August 2021 ]
    In this outcome measure participants with different treatment modalities including hormonotherapy and chemotherapy

  9. Time to Disease Free Interval [ Time Frame: 01 September 2020 through 31 August 2021 ]
    Last Dose of Last Drug Taken in Adjuvant Treatment

  10. Number of Participants With Association Between Disease Characteristic and ABC Treatment Patterns [ Time Frame: 01 September 2020 through 31 August 2021 ]
  11. Number of Participants With Association Between Clinical Characteristic and ABC Treatment Patterns [ Time Frame: 01 September 2020 through 31 August 2021 ]
  12. Number of Participants With Association Between Neoadjuvant Therapy and ABC Treatment Patterns [ Time Frame: 01 September 2020 through 31 August 2021 ]
  13. Number of Participants With Association Between Adjuvant Therapy and ABC Treatment Patterns [ Time Frame: 01 September 2020 through 31 August 2021 ]
  14. Number of Participants With Association Between Time to Relapse in early BC Treatment and ABC Treatment Patterns [ Time Frame: 01 September 2020 through 31 August 2021 ]
  15. Number of Participants With Association Between Concomitant Therapy and ABC Treatment Patterns [ Time Frame: 01 September 2020 through 31 August 2021 ]
  16. Proportion of Participants With Diagnosed Visceral Crisis [ Time Frame: 01 September 2020 through 31 August 2021 ]
  17. Number of Visceral Crisis Diagnosis in Compliance With ABC5 Guidelines [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05478590


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Poland
Pfizer Polska Recruiting
Warsaw, Poland
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05478590    
Other Study ID Numbers: A5481177
First Posted: July 28, 2022    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
Hormone receptor-positive human epidermal growth factor receptor 2 negative (HR+ HER2-)
advanced breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases