HR POSITIVE, HER 2 NEGATIVE ADVANCED BREAST CANCER- TREATMENT PATTERNS IN POLAND - HABER STUDY
Study analyzes breast cancer treatment patterns in Poland
Plain English Summary
A Study to Describe Treatment Patterns of Advanced Breast Cancer in Poland in the Real-world Data Setting is a Not Applicable clinical trial sponsored by Pfizer studying Breast Neoplasms. This study looked at how advanced breast cancer is treated in Poland. It focused on women with HR-positive, HER2-negative advanced breast cancer. Participation involved reviewing existing patient data, not new treatments. This study is observational, meaning it observes current practices, not a treatment trial. The trial aims to enroll 440 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adult patients diagnosed with advanced breast cancer (locally recurring or with distant spread). Patients must have HR-positive and HER2-negative breast cancer. Patients should not have received prior treatment for advanced breast cancer. Patients cannot have active cancer elsewhere or brain metastases. This trial is studying Breast Neoplasms, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the different ways HR+/HER2- advanced breast cancer was treated in Poland during a specific year, showing the variety of approaches used. The specific primary outcome measures are: Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns (01 September 2020 through 31 August 2021). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This study helps understand current breast cancer treatment practices in Poland, identifying potential gaps or areas for improvement in care for HR+/HER2- advanced breast cancer. This research targets Breast Neoplasms, where improved treatment options are needed.
Investor Insight
This observational study by Pfizer provides insights into real-world treatment patterns, which can inform future drug development and market strategies for advanced breast cancer therapies.
Is This Trial Right for Me?
Ask your doctor about the specific type of breast cancer you have and the recommended treatment options. Understand that this study reviews past treatment data and does not involve new interventions for patients. Discuss any concerns about your treatment plan and potential side effects with your healthcare team. The trial is being conducted at 19 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 440 participants
Primary Outcomes
- Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns (01 September 2020 through 31 August 2021)
Secondary Outcomes
- 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)
Full 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.
Trial Locations
- Ambulatorium Chemioterapii Centrum Onkologii, Bydgoszcz, Poland
- Wojewodzki Szpital Zespolony w Elblągu - oddzial onkologii, Elblag, Poland
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdansk, Poland
- Oddział onkologii Szpital Specjalistyczny im. H. Klimontowicza, Gorlice, Poland
- Oddział Onkologii Klinicznej, Kalisz, Poland
- Narodowy Instytut Onkologii, Krakow, Poland
- Oddział Onkologii Klinicznej z Pododdziałem Dziennym, Krakow, Poland
- Klinika Onkologii, Instytut Centrum Zdrowia Matki Polki, Lodz, Poland
- Opolskie Centrum Onkologii, Opole, Poland
- Oddział/Poradnia Onkologiczna Wojewodzki Szpital w Przemyślu, Przemyśl, Poland
- ...and 9 more locations
Frequently Asked Questions
What is clinical trial NCT05478590?
NCT05478590 is a Not Applicable OBSERVATIONAL study titled "A Study to Describe Treatment Patterns of Advanced Breast Cancer in Poland in the Real-world Data Setting." It is currently completed and is sponsored by Pfizer. The trial targets enrollment of 440 participants.
What conditions does NCT05478590 study?
This trial investigates treatments for Breast Neoplasms. The primary condition under study is Breast Neoplasms.
What does Not Applicable mean for NCT05478590?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05478590?
This trial is currently "Completed." It started on 2021-11-22. The estimated completion date is 2022-09-30.
Who is sponsoring NCT05478590?
NCT05478590 is sponsored by Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05478590?
The trial aims to enroll 440 participants. The trial status is completed.
How is NCT05478590 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05478590?
The primary outcome measures are: Number of Participants With HR+ HER2- Advanced Breast Cancer (ABC) Treatment Patterns (01 September 2020 through 31 August 2021). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05478590 being conducted?
This trial is being conducted at 19 sites, including Bydgoszcz; Elblag; Gdansk; Gorlice and 15 more sites (Poland).
Where can I find official information about NCT05478590?
The official record for NCT05478590 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05478590. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05478590 testing in simple terms?
This study looked at how advanced breast cancer is treated in Poland. It focused on women with HR-positive, HER2-negative advanced breast cancer.
Why is this trial significant?
This study helps understand current breast cancer treatment practices in Poland, identifying potential gaps or areas for improvement in care for HR+/HER2- advanced breast cancer.
What are the potential risks of participating in NCT05478590?
As this is an observational study, direct risks to patients are minimal as it reviews existing data. Potential risks are related to the treatments patients received for their advanced breast cancer, which may include side effects common to cancer therapies. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05478590?
Ask your doctor about the specific type of breast cancer you have and the recommended treatment options. Understand that this study reviews past treatment data and does not involve new interventions for patients. Discuss any concerns about your treatment plan and potential side effects with your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05478590 signal from an investment perspective?
This observational study by Pfizer provides insights into real-world treatment patterns, which can inform future drug development and market strategies for advanced breast cancer therapies. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involved reviewing existing patient data, not new treatments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Breast Neoplasms Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.