Breast Cancer MetastaticSTORMNCT06728150
Study Investigating the Role of Routine Screening and Molecular Characterisation of Brain Metastasis in the Management of High-risk Metastatic Breast Cancer
An observational study of Breast Cancer Metastatic and Brain Metastasases, run by Monash University at 1 site in Australia.
Trial summary
The purpose of this study is to improve outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Metastatic, Brain Metastasases
- What is being tested?
- computerized tomography
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2024to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of metastatic breast cancer.
Who may be able to join
- Metastatic breast cancer with visceral, nodal or bone metastasis
- Human epidermal growth factor type2 (HER2-positive disease)
- Triple negative breast cancer (TNBC) with metastatic disease
- Oestrogen Receptor Positive disease (ER-positive disease) after second-line therapy and cyclin dependent kinase 4/6 inhibitors (CDK4/6 inhibitors), plus more than two sites of bone metastasis or visceral metastasis
- Diagnosis of metastatic disease in the last 3 months and free of symptoms or disease (with brain MRI confirmation) • Medicare Eligible
Who cannot join
- Symptomatic brain metastasis
- Inability to provide consent
- Inadequate organ function
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to improve outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging.
In patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging. However, there is emerging evidence suggesting that patients diagnosed without symptoms of brain metastases may have a better outcome than those with symptoms such as headache, vomiting and weakness.
Read more
In current practice, if signs and symptoms suggestive of brain metastases are to develop, then the doctor will arrange imaging of the brain, which may be a computerised tomography (CT scan) and/or a magnetic resonance imaging (MRI) scan. Should brain metastasis be detected, local radiotherapy, chemotherapy or targeted treatments will be offered.
When initially diagnosed with metastatic or advanced breast cancer, participant will or would have undergone a brain scan by either MRI or CT during normal standard full-body CT scan (chest, abdomen and pelvis) imaging. In this study, each time participants have a regular full-body CT scans to assess treatment progress, they will also have an additional CT scan of the brain.
Participants will have a total of 12 extra brain scans, with scans taking place every three months for the first 2 years, and every 6 months for the following years. These scans will occur at the same location as your current treatment. There will be no extra costs involved in the study and participants will be in the study for 4 years and following their follow-up details will be collected from medical records.
Some participants who develop brain metastases during the followup will have neurosurgery to remove these metastases. The investigators will collect either fresh or archived tissues and a cerebrospinal fluid (CSF) sample at the time of surgery from those patients.
If the treating investigators do not think neurosurgery is an option, they will ask participants to have a lumbar puncture for the collection of CSF. The purpose of this optional CSF collection is to take a liquid biopsy to check for markers (or biomarkers) potentially expressed by the breast cancer tumour cells in the brain. Participants will also be asked to provide a blood sample as well as old tumour from breast surgery (other metastatic tumour tissue).
The information obtained from this component of the study will not impact a parcipants current management, but it will help researchers to develop better treatments for breast cancer brain metastases in the future.
- Conditions
- Breast Cancer Metastatic, Brain Metastasases
- Being tested
- computerized tomography
- Keywords
- Breast cancer brain metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized tomographyRadiation
The patients will have 3 monthly CT scans of the brain for 2 years and 6 monthly CT scans for 2 years for total of 4 years.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of screen-detected asymptomatic brain metastasis.
CT scan of the brain used to determine evidence of new metastases.
Measured: 12 months
Secondary outcomes (6)
Incidence of symptomatic brain metastases
CT scans of the brain
Measured: Though to study completion, an average of 1 year
Progression free survival
Time form entry into the study to brain metastases development
Measured: Though to study completion, an average of 1 year
Overall survival
Time form entry into the study to death
Measured: Though to study completion, an average of 1 year
Number of surgical resections
The number of patients who develop brain metastases having surgery
Measured: Though to study completion, an average of 1 year
Rate of stereotactic radiotherapy
The number of patients having stereotactic radiotherapy assesses using medical records
Measured: Though to study completion, an average of 1 year
Evaluation of the role of early treatment on intracranial disease control
Time form initial surgical or radiotherapy or observation to progression of disease
Measured: Though to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred, Breast Cancer Trials, Australia and New Zealand
- Responsible party
- Principal investigator, Mahesh Iddawela, Monash University
- Investigators
- Mahesh Iddawela, MBBS FRACP PhD, Principal investigator, Associate Professor and Medical Oncologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728150
- Sponsor's protocol ID
- Project 331/22
- Acronym
- STORM
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The details of the protocol, patient information sheet, de-identified data and analysis
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Investigating the Role of Routine Screening and Molecular Characterisation of Brain Metastasis in the Management of High-risk Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06728150
- Acronym / sponsor ID
- STORM / Project 331/22
- Conditions
- Breast Cancer Metastatic, Brain Metastasases
- Keywords
- Breast cancer brain metastases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- The Alfred, Breast Cancer Trials, Australia and New Zealand
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to improve outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging.
In patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging. However, there is emerging evidence suggesting that patients diagnosed without symptoms of brain metastases may have a better outcome than those with symptoms such as headache, vomiting and weakness.
In current practice, if signs and symptoms suggestive of brain metastases are to develop, then the doctor will arrange imaging of the brain, which may be a computerised tomography (CT scan) and/or a magnetic resonance imaging (MRI) scan. Should brain metastasis be detected, local radiotherapy, chemotherapy or targeted treatments will be offered.
When initially diagnosed with metastatic or advanced breast cancer, participant will or would have undergone a brain scan by either MRI or CT during normal standard full-body CT scan (chest, abdomen and pelvis) imaging. In this study, each time participants have a regular full-body CT scans to assess treatment progress, they will also have an additional CT scan of the brain.
Participants will have a total of 12 extra brain scans, with scans taking place every three months for the first 2 years, and every 6 months for the following years. These scans will occur at the same location as your current treatment. There will be no extra costs involved in the study and participants will be in the study for 4 years and following their follow-up details will be collected from medical records.
Some participants who develop brain metastases during the followup will have neurosurgery to remove these metastases. The investigators will collect either fresh or archived tissues and a cerebrospinal fluid (CSF) sample at the time of surgery from those patients.
If the treating investigators do not think neurosurgery is an option, they will ask participants to have a lumbar puncture for the collection of CSF. The purpose of this optional CSF collection is to take a liquid biopsy to check for markers (or biomarkers) potentially expressed by the breast cancer tumour cells in the brain. Participants will also be asked to provide a blood sample as well as old tumour from breast surgery (other metastatic tumour tissue).
The information obtained from this component of the study will not impact a parcipants current management, but it will help researchers to develop better treatments for breast cancer brain metastases in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of metastatic breast cancer.
Key inclusion criteria (5 listed)
- Metastatic breast cancer with visceral, nodal or bone metastasis
- Human epidermal growth factor type2 (HER2-positive disease)
- Triple negative breast cancer (TNBC) with metastatic disease
- Oestrogen Receptor Positive disease (ER-positive disease) after second-line therapy and cyclin dependent kinase 4/6 inhibitors (CDK4/6 inhibitors), plus more than two sites of bone metastasis or visceral metastasis
- Diagnosis of metastatic disease in the last 3 months and free of symptoms or disease (with brain MRI confirmation) • Medicare Eligible
Key exclusion criteria (4 listed)
- Symptomatic brain metastasis
- Inability to provide consent
- Inadequate organ function
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computerized tomographyThe patients will have 3 monthly CT scans of the brain for 2 years and 6 monthly CT scans for 2 years for total of 4 years. | Radiation | – |
Primary outcome
Incidence of screen-detected asymptomatic brain metastasis.
Time frame: 12 months
CT scan of the brain used to determine evidence of new metastases.
6 secondary outcomes
Incidence of symptomatic brain metastases
Time frame: Though to study completion, an average of 1 year
Progression free survival
Time frame: Though to study completion, an average of 1 year
Overall survival
Time frame: Though to study completion, an average of 1 year
Number of surgical resections
Time frame: Though to study completion, an average of 1 year
Rate of stereotactic radiotherapy
Time frame: Though to study completion, an average of 1 year
Evaluation of the role of early treatment on intracranial disease control
Time frame: Though to study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes. The details of the protocol, patient information sheet, de-identified data and analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahesh Iddawela, MBBS FRACP PhD principal investigator
Associate Professor and Medical Oncologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Metastatic and Brain Metastasases, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahesh Iddawela, MBBS FRACP PhD (61351738000, mahesh.iddawela@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of screen-detected asymptomatic brain metastasis. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.