Palbociclib Treatment Patterns in Swedish Patients With Metastatic Breast Cancer - Swedish Ibrance Registries Insights (SIRI)
Study tracks how breast cancer drug palbociclib is used in Sweden
Plain English Summary
Swedish Ibrance Registries Insights (SIRI) is a Not Applicable clinical trial sponsored by Pfizer studying Malignant Neoplasm of Breast. This study observes how a drug called palbociclib is used in real-world clinical practice for patients with metastatic breast cancer in Sweden. It is for adult patients in Sweden who have been prescribed palbociclib for metastatic breast cancer. Participation involves reviewing existing medical records and prescription data; no new treatments or procedures are required. There are no direct alternatives to participation as this is an observational study of current treatment practices. The trial aims to enroll 1500 participants.
Official Summary
The main objectives of this study are to describe patient characteristics, treatment patterns and clinical outcomes of patients receiving palbociclib in Swedish clinical practice.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 or older in Sweden who have received at least one prescription for palbociclib. Patients must have metastatic breast cancer. There are no specific health requirements beyond having been prescribed the study drug. This trial is studying Malignant Neoplasm of Breast, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how many patients received the drug, giving a clear picture of its uptake and use in routine care. The specific primary outcome measures are: Proportion of patients on treatment (01 January 2017 until 30 September 2020). 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 trial matters because it will provide valuable insights into how palbociclib is actually used in Sweden, helping to understand its effectiveness and patterns of care for metastatic breast cancer. This research targets Malignant Neoplasm of Breast, where improved treatment options are needed.
Investor Insight
This observational study on palbociclib, a known breast cancer drug, signals continued interest in real-world data for market understanding and potential future treatment guidelines, though it does no The large enrollment target of 1500 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if palbociclib is the right treatment for your metastatic breast cancer. Your participation is based on existing prescription data, so you do not need to do anything extra day-to-day. The study will look at your medical history and how you responded to treatment based on records. This trial is currently recruiting participants. The trial is being conducted at 1 site. 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: 1,500 participants
Interventions
- DRUG: palbociclib — patients on palbociclib combination treatment
Primary Outcomes
- Proportion of patients on treatment (01 January 2017 until 30 September 2020)
Secondary Outcomes
- Proportion of patients alive (01 January 2017 until 30 September 2020)
- Describe the demographic and clinical characteristics of the patient population receiving palbociclib combination treatment (01 January 2017 until 30 September 2020)
Full Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. One or more (≥1) filled prescription of palbociclib (ATC code: L01XE33) 2. Age ≥18 years at index date Exclusion Criteria: There are no exclusion criteria
Trial Locations
- Pfizer Sweden, Sollentuna, Sweden
Frequently Asked Questions
What is clinical trial NCT04654208?
NCT04654208 is a Not Applicable OBSERVATIONAL study titled "Swedish Ibrance Registries Insights (SIRI)." It is currently recruiting and is sponsored by Pfizer. The trial targets enrollment of 1500 participants.
What conditions does NCT04654208 study?
This trial investigates treatments for Malignant Neoplasm of Breast. The primary condition under study is Malignant Neoplasm of Breast.
What treatments are being tested in NCT04654208?
The interventions being studied include: palbociclib (DRUG). patients on palbociclib combination treatment
What does Not Applicable mean for NCT04654208?
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 NCT04654208?
This trial is currently "Recruiting." It started on 2020-12-15. The estimated completion date is 2026-05-31.
Who is sponsoring NCT04654208?
NCT04654208 is sponsored by Pfizer. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04654208?
The trial aims to enroll 1500 participants. The trial is currently recruiting and accepting new participants.
How is NCT04654208 designed?
This is a observational study.
What are the primary outcomes being measured in NCT04654208?
The primary outcome measures are: Proportion of patients on treatment (01 January 2017 until 30 September 2020). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04654208 being conducted?
This trial is being conducted at 1 site, including Sollentuna (Sweden).
Where can I find official information about NCT04654208?
The official record for NCT04654208 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04654208. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04654208 testing in simple terms?
This study observes how a drug called palbociclib is used in real-world clinical practice for patients with metastatic breast cancer in Sweden. It is for adult patients in Sweden who have been prescribed palbociclib for metastatic breast cancer.
Why is this trial significant?
This trial matters because it will provide valuable insights into how palbociclib is actually used in Sweden, helping to understand its effectiveness and patterns of care for metastatic breast cancer.
What are the potential risks of participating in NCT04654208?
As this is an observational study, direct risks are minimal as no new interventions are given. Potential side effects are those associated with palbociclib itself, which your doctor will discuss with you. The study uses anonymized data, protecting your personal health information. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04654208?
Ask your doctor if palbociclib is the right treatment for your metastatic breast cancer. Your participation is based on existing prescription data, so you do not need to do anything extra day-to-day. The study will look at your medical history and how you responded to treatment based on records. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04654208 signal from an investment perspective?
This observational study on palbociclib, a known breast cancer drug, signals continued interest in real-world data for market understanding and potential future treatment guidelines, though it does no This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves reviewing existing medical records and prescription data; no new treatments or procedures are required. 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 Malignant Neoplasm of Breast Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.