A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
Study tracks breast cancer patients to understand disease patterns.
Plain English Summary
A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC) is a Not Applicable clinical trial sponsored by Spanish Breast Cancer Research Group studying Breast Neoplasms. This study collects information on patients with advanced or metastatic breast cancer. It is for individuals diagnosed with this type of breast cancer. Participation involves allowing researchers to access your medical records and data. There is no new treatment being tested; it's an observational study. The trial aims to enroll 1867 participants.
Official Summary
This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have been diagnosed with unresectable locally advanced or metastatic breast cancer since January 2016. Patients who have passed away can also be included if their records are available. You must be able to provide consent if you are alive. There are no exclusion criteria listed, meaning it's broadly inclusive for eligible patients. This trial is studying Breast Neoplasms, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures the actual distribution of different breast cancer subtypes in patients, helping doctors understand the types of advanced breast cancer being treated. The specific primary outcome measures are: Number of patients with the different breast cancer subtypes and real distribution of them. (8 years). 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 aims to build a comprehensive understanding of how advanced breast cancer behaves in real-world settings, filling a gap in knowledge about disease progression and subtype This research targets Breast Neoplasms, where improved treatment options are needed.
Investor Insight
This registry study provides valuable real-world data on a significant patient population, which can inform future treatment strategies and potentially attract investment in related research areas. The large enrollment target of 1867 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about how your information will be used and protected. Participation means your medical history and treatment data will be reviewed by researchers. This is a long-term study, so your data will be followed for up to 8 years. This trial is currently recruiting participants. The trial is being conducted at 20 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: 1,867 participants
Interventions
- OTHER: No intervention
Primary Outcomes
- Number of patients with the different breast cancer subtypes and real distribution of them. (8 years)
Secondary Outcomes
- Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk. (8 years)
- Differences in the development disease in the group of male vs female patients. (8 years)
- Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis (8 years)
- Number of participants with specific biomarkers on tumor and blood samples. (8 years)
Full Eligibility Criteria
Inclusion Criteria: 1. Patients (males or females) diagnosed with unresectable locally advanced or MBC (either after a recurrence or as first diagnosis) from January 2016 onwards. 2. Patients who died are allowed to be included on the study. 3. Able and willing to provide written informed consent if they are alive. 4. Age ≥ 18 years. 5. Availability to medical records access and all data related to the disease management. Exclusion Criteria: None
Trial Locations
- Hospital General de Elche, Elche, Alicante, Spain
- Althaia-Xarxa Assistencial de Manresa, Manresa, Barcelona, Spain
- Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain
- Hospital Universitario Donostia, San Sebastián, Donostia, Spain
- Hospital Dr. Negrín, Las Palmas de Gran Canaria, Gran Canaria, Spain
- Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain
- Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain
- Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain
- Hospital Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain
- Hospital Son Llatzer, Palma de Mallorca, Mallorca, Spain
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT02819882?
NCT02819882 is a Not Applicable OBSERVATIONAL study titled "A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)." It is currently recruiting and is sponsored by Spanish Breast Cancer Research Group. The trial targets enrollment of 1867 participants.
What conditions does NCT02819882 study?
This trial investigates treatments for Breast Neoplasms. The primary condition under study is Breast Neoplasms.
What treatments are being tested in NCT02819882?
The interventions being studied include: No intervention (OTHER).
What does Not Applicable mean for NCT02819882?
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 NCT02819882?
This trial is currently "Recruiting." It started on 2016-08. The estimated completion date is 2026-06.
Who is sponsoring NCT02819882?
NCT02819882 is sponsored by Spanish Breast Cancer Research Group. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT02819882?
The trial aims to enroll 1867 participants. The trial is currently recruiting and accepting new participants.
How is NCT02819882 designed?
This is a observational study.
What are the primary outcomes being measured in NCT02819882?
The primary outcome measures are: Number of patients with the different breast cancer subtypes and real distribution of them. (8 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT02819882 being conducted?
This trial is being conducted at 20 sites, including Elche, Alicante; Manresa, Barcelona; Terrassa, Barcelona; San Sebastián, Donostia and 16 more sites (Spain).
Where can I find official information about NCT02819882?
The official record for NCT02819882 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT02819882. This government database provides the most up-to-date and detailed information about the trial.
What is NCT02819882 testing in simple terms?
This study collects information on patients with advanced or metastatic breast cancer. It is for individuals diagnosed with this type of breast cancer.
Why is this trial significant?
This trial matters because it aims to build a comprehensive understanding of how advanced breast cancer behaves in real-world settings, filling a gap in knowledge about disease progression and subtype
What are the potential risks of participating in NCT02819882?
As this is an observational study, the main risk is related to the privacy of your medical information. There are no direct risks from study procedures, as no new treatments are being given. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT02819882?
Ask your doctor about how your information will be used and protected. Participation means your medical history and treatment data will be reviewed by researchers. This is a long-term study, so your data will be followed for up to 8 years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT02819882 signal from an investment perspective?
This registry study provides valuable real-world data on a significant patient population, which can inform future treatment strategies and potentially attract investment in related research areas. 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 allowing researchers to access your medical records and data. 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.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.