A Pilot Study on the Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer
Blood test for advanced HER2-low breast cancer
Plain English Summary
Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer is a Not Applicable clinical trial sponsored by European Institute of Oncology studying Advanced Metastatic Breast Cancer. This study looks at a blood test that detects tiny pieces of cancer DNA (called ctDNA) in people with advanced or spreading breast cancer that has low levels of a protein called HER2. It is for patients with advanced or metastatic breast cancer that is HER2-low. Participation involves providing a blood sample for analysis. Patients will be followed for up to 12 months. Standard treatment for this type of breast cancer is the main alternative, but this study aims to find new ways to monitor the disease. The trial aims to enroll 30 participants.
Official Summary
A Pilot study on circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low)
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have been diagnosed with HER2-low breast cancer that has spread or is advanced. HER2-low means your cancer has a score of 1+ or 2+ for HER2 protein, and it's not amplified. You must be able to attend follow-up appointments. You cannot join if you have not provided informed consent. This trial is studying Advanced Metastatic Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how much cancer DNA is found in the blood over 12 months, which could help doctors understand how the cancer is behaving without needing more invasive tests. The specific primary outcome measures are: circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low) (12 months). 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 explores a less invasive way to understand and potentially monitor HER2-low advanced breast cancer, addressing a gap in current diagnostic tools. This research targets Advanced Metastatic Breast Cancer, where improved treatment options are needed.
Investor Insight
This pilot study on ctDNA in a specific breast cancer subtype signals potential for new diagnostic tools, which could represent a growing market for precision oncology diagnostics if validated.
Is This Trial Right for Me?
Ask your doctor if this blood test is right for you and how it might help manage your cancer. Participation involves giving a blood sample and attending follow-up visits as scheduled. The day-to-day impact is minimal, mainly involving clinic visits for blood draws and check-ups. 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: 30 participants
Primary Outcomes
- circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low) (12 months)
Full Eligibility Criteria
Inclusion Criteria * Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing. * Participants should be at advanced or metastatic setting prior to treatment. * Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion. * Patients must be accessible for follow-up.
Trial Locations
- European Institute of Oncology, Milan, MI, Italy
Frequently Asked Questions
What is clinical trial NCT06706557?
NCT06706557 is a Not Applicable OBSERVATIONAL study titled "Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer." It is currently recruiting and is sponsored by European Institute of Oncology. The trial targets enrollment of 30 participants.
What conditions does NCT06706557 study?
This trial investigates treatments for Advanced Metastatic Breast Cancer. The primary condition under study is Advanced Metastatic Breast Cancer.
What does Not Applicable mean for NCT06706557?
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 NCT06706557?
This trial is currently "Recruiting." It started on 2024-01-11. The estimated completion date is 2030-12-31.
Who is sponsoring NCT06706557?
NCT06706557 is sponsored by European Institute of Oncology. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06706557?
The trial aims to enroll 30 participants. The trial is currently recruiting and accepting new participants.
How is NCT06706557 designed?
This is a observational study.
What are the primary outcomes being measured in NCT06706557?
The primary outcome measures are: circulating tumor DNA (ctDNA) in advanced/metastatic breast cancer with low levels of HER2 expression (HER2 low) (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06706557 being conducted?
This trial is being conducted at 1 site, including Milan, MI (Italy).
Where can I find official information about NCT06706557?
The official record for NCT06706557 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06706557. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06706557 testing in simple terms?
This study looks at a blood test that detects tiny pieces of cancer DNA (called ctDNA) in people with advanced or spreading breast cancer that has low levels of a protein called HER2. It is for patients with advanced or metastatic breast cancer that is HER2-low.
Why is this trial significant?
This trial matters because it explores a less invasive way to understand and potentially monitor HER2-low advanced breast cancer, addressing a gap in current diagnostic tools.
What are the potential risks of participating in NCT06706557?
The main risk is that the blood test might not detect ctDNA even if cancer is present, or it might detect it when it's not clinically significant. Potential side effects are related to blood draws, such as bruising or minor discomfort at the needle site. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06706557?
Ask your doctor if this blood test is right for you and how it might help manage your cancer. Participation involves giving a blood sample and attending follow-up visits as scheduled. The day-to-day impact is minimal, mainly involving clinic visits for blood draws and check-ups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06706557 signal from an investment perspective?
This pilot study on ctDNA in a specific breast cancer subtype signals potential for new diagnostic tools, which could represent a growing market for precision oncology diagnostics if validated. 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 providing a blood sample for analysis. Patients will be followed for up to 12 months. 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 Advanced Metastatic Breast Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.