SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveilla
Feasibility study tests brain scan surveillance for HER2+ breast cancer patients
Plain English Summary
SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance is a Not Applicable clinical trial sponsored by Royal College of Surgeons, Ireland studying Breast Cancer, HER2-Positive Metastatic Breast Cancer. This study tests if it's possible to randomly assign patients with HER2-positive metastatic breast cancer to either regular brain scans or standard care (scans only if symptoms appear). It is for women and men with HER2-positive breast cancer that has spread to other parts of the body. Participation involves a baseline brain MRI, and then either regular MRIs over 12 months or only getting an MRI if symptoms develop. The alternative is standard care, where brain scans are only done if symptoms of brain involvement arise. The trial aims to enroll 69 participants.
Official Summary
SURVEY-CNS is a feasibility study evaluating whether women and men with HER2-positive metastatic breast cancer can be successfully recruited and randomised to a strategy of central nervous system (CNS) magnetic resonance imaging (MRI) surveillance versus standard of care (no routine CNS surveillance). Patients with HER2-positive metastatic breast cancer have a high risk of developing brain metastases. Brain metastases can cause significant symptoms, including headache, nausea, seizures, visual disturbance, motor dysfunction, and cognitive or psychological changes. Although new HER2-directed therapies have improved systemic disease control, CNS progression remains common and is associated with reduced quality of life and survival. Currently, routine brain imaging is not recommended in asymptomatic patients. Brain imaging is typically performed only when neurological symptoms develop. Observational data suggest that patients diagnosed with asymptomatic brain metastases may have better outcomes than those diagnosed after symptoms occur. However, it is not known whether a surveillance strategy is feasible or acceptable to patients. All participants in this study will undergo a baseline contrast-enhanced brain MRI. Patients without evidence of CNS metastases on the baseline scan will be randomised (1:1) to either: CNS surveillance with repeat brain MRI at 6 and 12 months, or No routine surveillance imaging (standard of care), with imaging only if clinically indicated. The primary objective is to determine whether more than 30% of eligible patients approached agree to undergo screening and randomisation. The study will approach up to 193 patients and will be considered feasible if 69 patients consent to screening with intent to randomise. Secondary objectives include: Determining the proportion of patients with previously undetected (occult) CNS metastases at baseline; Determining the incidence of occult CNS metastases during surveillance; Recording symptomatic CNS
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have HER2-positive breast cancer that has spread, are receiving treatment targeting HER2, and are generally well enough to participate. You cannot join if you have had brain metastases before, have symptoms of brain metastases, or cannot have MRI scans or contrast dye. Your cancer must have spread to organs other than just bone. You must be able to give consent and follow the study's procedures. This trial is studying Breast Cancer, HER2-Positive Metastatic Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if most eligible patients agree to be randomized, which will tell us if this type of study is practical to conduct. The specific primary outcome measures are: Proportion of Eligible Patients Consenting to Screening and Randomisation (Through recruitment completion, an average of 24 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 new approach to detect and manage brain metastases in HER2-positive breast cancer, addressing a gap where early detection might improve outcomes. This research targets Breast Cancer, HER2-Positive Metastatic Breast Cancer, where improved treatment options are needed.
Investor Insight
This is a feasibility study, not directly testing treatment efficacy, but it addresses a significant unmet need in a large patient population, potentially paving the way for larger trials.
Is This Trial Right for Me?
Ask your doctor about the risks and benefits of regular brain scans versus waiting for symptoms. Understand that you will have a baseline brain MRI, and then either scheduled follow-up MRIs or only MRIs if you develop symptoms. Be prepared for potential MRI appointments and any associated travel. 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: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 69 participants
Interventions
- DIAGNOSTIC_TEST: Brain Magnetic Resonance Imaging (MRI) with Contrast — Contrast-enhanced MRI of the brain performed according to local institutional standards. In the surveillance arm, MRI is performed at baseline, 6 months, and 12 months. In the standard-of-care arm, MRI is performed at baseline only, with additional imaging if clinically indicated.
Primary Outcomes
- Proportion of Eligible Patients Consenting to Screening and Randomisation (Through recruitment completion, an average of 24 months.)
Secondary Outcomes
- Proportion of Patients With Occult CNS Metastases at Baseline MRI (At baseline (prior to randomisation))
- Proportion of Patients With Radiologically Detected CNS Metastases During Surveillance (Up to 12 months after randomisation)
- Proportion of Patients Developing Symptomatic CNS Disease (Up to 14 months after baseline)
- Description of Initial Local Treatment for CNS Metastases (Up to 14 months after baseline)
- Systemic Anti-Cancer Therapy (SACT) Modification Following CNS Diagnosis (Up to 14 months after baseline)
Full Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Male or female * Histologically or cytologically confirmed HER2-positive breast cancer * Evidence of metastatic breast cancer * Estrogen receptor (ER) positive or negative disease permitted * Presence of visceral metastatic disease * Receiving active HER2-directed systemic therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Estimated life expectancy greater than 6 months * Ability to provide written informed consent * Willing and able to comply with study procedures and follow-up Exclusion Criteria: * Prior history of brain metastases * History or evidence of leptomeningeal carcinomatosis * Symptoms suggestive of brain metastases at screening * Bone-only metastatic disease * Inability to undergo MRI scanning * Known hypersensitivity or contraindication to MRI contrast agents that cannot - be managed per local standard of care * Significant medical condition or laboratory abnormality that, in the opinion of - the investigator, makes participation inappropriate Inability to provide informed consent * Deemed unsuitable for participation by the principal investigator due to clinical, mobility, or social circumstances
Trial Locations
- Beaumont RCSI Cancer Centre, Beaumont, Ireland
Frequently Asked Questions
What is clinical trial NCT07503717?
NCT07503717 is a Not Applicable INTERVENTIONAL study titled "SURVEY-CNS: A Feasibility Study of Randomising Women and Men With HER2-Positive Metastatic Breast Cancer to Central Nervous System Surveillance Versus No Surveillance." It is currently recruiting and is sponsored by Royal College of Surgeons, Ireland. The trial targets enrollment of 69 participants.
What conditions does NCT07503717 study?
This trial investigates treatments for Breast Cancer, HER2-Positive Metastatic Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT07503717?
The interventions being studied include: Brain Magnetic Resonance Imaging (MRI) with Contrast (DIAGNOSTIC_TEST). Contrast-enhanced MRI of the brain performed according to local institutional standards. In the surveillance arm, MRI is performed at baseline, 6 months, and 12 months. In the standard-of-care arm, MRI is performed at baseline only, with additional imaging if clinically indicated.
What does Not Applicable mean for NCT07503717?
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 NCT07503717?
This trial is currently "Recruiting." It started on 2025-06-01. The estimated completion date is 2028-06-01.
Who is sponsoring NCT07503717?
NCT07503717 is sponsored by Royal College of Surgeons, Ireland. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07503717?
The trial aims to enroll 69 participants. The trial is currently recruiting and accepting new participants.
How is NCT07503717 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07503717?
The primary outcome measures are: Proportion of Eligible Patients Consenting to Screening and Randomisation (Through recruitment completion, an average of 24 months.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07503717 being conducted?
This trial is being conducted at 1 site, including Beaumont (Ireland).
Where can I find official information about NCT07503717?
The official record for NCT07503717 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07503717. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07503717 testing in simple terms?
This study tests if it's possible to randomly assign patients with HER2-positive metastatic breast cancer to either regular brain scans or standard care (scans only if symptoms appear). It is for women and men with HER2-positive breast cancer that has spread to other parts of the body.
Why is this trial significant?
This trial matters because it explores a new approach to detect and manage brain metastases in HER2-positive breast cancer, addressing a gap where early detection might improve outcomes.
What are the potential risks of participating in NCT07503717?
The main risk is the inconvenience and potential anxiety associated with regular MRI scans. There's a small risk of allergic reaction to the MRI contrast dye. If brain metastases are found, it could lead to further medical procedures and treatments. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07503717?
Ask your doctor about the risks and benefits of regular brain scans versus waiting for symptoms. Understand that you will have a baseline brain MRI, and then either scheduled follow-up MRIs or only MRIs if you develop symptoms. Be prepared for potential MRI appointments and any associated travel. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07503717 signal from an investment perspective?
This is a feasibility study, not directly testing treatment efficacy, but it addresses a significant unmet need in a large patient population, potentially paving the way for larger trials. 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 a baseline brain MRI, and then either regular MRIs over 12 months or only getting an MRI if symptoms develop. 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 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.