Breast NeoplasmSYMPToMNCT03881605
MRI Screening Versus SYMptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative or HER2+ MBC
A study testing MRI screening in people with Breast Neoplasm and Brain Metastases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre. They will be randomized to undergo either routine MRI screening of their brain every 4 months for 1 year or standard-of-care (MRI only if… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm, Brain Metastases, Triple Negative Breast Cancer
- What is being tested?
- MRI screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2018to Dec 2025
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- Triple negative or HER2+ breast cancer (ASCO/CAP guidelines 2018)*
- MBC, as defined as distant disease outside of the breast and local/regional lymph nodes. Physicians' clinical judgment will be used to determine the possible need for biopsy in confirming a MBC diagnosis. However, biopsy of a metastatic site is not required for pathologic confirmation of stage IV disease.
- Diagnosis of metastatic disease within 12 weeks prior to study enrollment.
- No symptoms of BrM or known asymptomatic BrM at study entry.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may participate.
- This will generally be based on the primary cancer but in the event that a metastatic site is biopsied eligibility will be based on the ER, PR and HER2 profile of the metastasis.
Who cannot join
- Inability to participate in an MRI screening program as determined by the patient and/or physician. This may be on the basis of severe claustrophobia, performance status that limits additional testing, or a metal foreign body that would prevent MRI imaging.
- Inability to provide informed consent. Notably participants who require translators are allowed to enroll.
- Creatinine clearance <30 mL/min using the Cockcroft-Gault equation.
- Established need for brain imaging apart from the breast cancer diagnosis (e.g surveillance for an aneurysm).
- ECOG Performance status >2.
- Pregnancy.
- Grade 3+ allergy to Gadavist IV contrast (CTEP Adverse Event Reporting System).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routine MRI Screening Versus Symptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative and HER2+ Metastatic Breast Cancer (MBC): a Single-centre Randomized Pilot Study
In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre. They will be randomized to undergo either routine MRI screening of their brain every 4 months for 1 year or standard-of-care (MRI only if symptoms of brain metastases develop). Patients will complete questionnaires about quality of life and cancer-related anxiety throughout the study. To determine why some cancers spread to the brain and others do not, blood samples will be collected to analyze the genetic makeup of patients' breast cancers. Finally, a novel MRI imaging technique that detects abnormal metabolism in the brain will be used to help detect brain metastases even earlier than the standard MRI.
If results are promising, we will conduct a large multi-centre randomized trial to determine whether screening for brain metastases can help them live longer with improved quality of life.
Read the detailed description
Please see trial details below.
- Conditions
- Breast Neoplasm, Brain Metastases, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- Being tested
- MRI screening
- Keywords
- MRI, Screening, Quality of life, Surveillance
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI screeningDiagnostic test
A standard contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain will be performed at baseline, 4 months, 8 months and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| MRI screening | Experimental | Contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain at baseline, 4 months, 8 months and 12 months. Receives: Diagnostic Test: MRI screening |
| Symptom-directed surveillance | No intervention | Imaging of the brain will take place only if patients develop symptoms that are suggestive of brain metastases (e.g. headaches, vision changes, gait instability). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible patients at the Sunnybrook Odette Cancer Centre (SOCC) who i) agree to enroll in the proposed randomized phase II pilot study, and ii) complete the study protocol.
This outcome is intended to assess the feasibility of a future large, multi-center randomized trial.
Measured: 15 months.
Secondary outcomes (9)
Proportion of patients in the control arm who undergo imaging of the brain with CT or MRI.
This outcome is intended to assess the incidence of screening "contamination" in the control arm of the study.
Measured: 12 months
Incidence of symptomatic brain metastases.
To be assessed in both study arms.
Measured: Baseline, 4-, 8- and 12-months.
Number of interventions used to treat brain metastases.
To be assessed in both study arms.
Measured: 15 months
Size and location of BrM per patient.
To be assessed in both study arms.
Measured: At the time of diagnosis of brain metastases (from enrollment to 15 months)
Neurologic-specific quality-of-life (The Functional Assessment of Cancer Therapy-Brain; FACT-BR version 4 tool).
To be assessed in both study arms; 37 questions are rated from a scale of 0 to 4 (total score 0 to 185 where a lower score indicates better quality-of-life)
Measured: Baseline, 6 months and 15 months.
Overall quality-of-life (EORTC core quality of life questionnaire; EORTC QLQ-C30 version 3 tool).
To be assessed in both study arms; ; 30 questions are rated from a scale of 1 to 4 (total score 30 to 120 where a lower score indicates better quality-of-life)
Measured: Baseline, 6 months and 15 months.
Cancer-related anxiety (NCI PRO-CTCAE for anxiety).
To be assessed in both study arms.
Measured: Baseline, 6 months and 15 months.
Time to death due to any cause.
To be assessed in both study arms.
Measured: 15 months.
Time to death due to neurologic progression.
To be assessed in both study arms.
Measured: 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start8 Nov 2018
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University
- Responsible party
- Principal investigator, Dr. Katarzyna Jerzak, Sunnybrook Health Sciences Centre
- Investigators
- Katarzya J Jerzak, MD MSc FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881605
- Sponsor's protocol ID
- 211-2018
- Acronym
- SYMPToM
- Status last verified
- Jan 2025
- First submitted
- 14 Mar 2019
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD which does not include any patient identifiers will be considered but will require Research Ethics Board approval and appropriate legal contracts between collaborating institutions to ensure protection of patient data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine MRI Screening Versus Symptom-directed Surveillance for Brain Metastases Among Patients with Triple Negative and HER2+ Metastatic Breast Cancer (MBC): a Single-centre Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03881605
- Acronym / sponsor ID
- SYMPToM / 211-2018
- Conditions
- Breast Neoplasm, Brain Metastases, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- Keywords
- MRI, Screening, Quality of life, Surveillance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Harvard University
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Mar 2019 (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.
In this study, 50 women with either HER2+ or triple negative metastatic breast cancer but no known brain metastases will be recruited at the Sunnybrook Odette Cancer Centre. They will be randomized to undergo either routine MRI screening of their brain every 4 months for 1 year or standard-of-care (MRI only if symptoms of brain metastases develop). Patients will complete questionnaires about quality of life and cancer-related anxiety throughout the study. To determine why some cancers spread to the brain and others do not, blood samples will be collected to analyze the genetic makeup of patients' breast cancers. Finally, a novel MRI imaging technique that detects abnormal metabolism in the brain will be used to help detect brain metastases even earlier than the standard MRI.
If results are promising, we will conduct a large multi-centre randomized trial to determine whether screening for brain metastases can help them live longer with improved quality of life.
Detailed description
Please see trial details below.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| MRI screening | Experimental | Diagnostic Test: MRI screeningContrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain at baseline, 4 months, 8 months and 12 months. |
| Symptom-directed surveillance | No intervention | –Imaging of the brain will take place only if patients develop symptoms that are suggestive of brain metastases (e.g. headaches, vision changes, gait instability). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18
- Triple negative or HER2+ breast cancer (ASCO/CAP guidelines 2018)*
- MBC, as defined as distant disease outside of the breast and local/regional lymph nodes. Physicians' clinical judgment will be used to determine the possible need for biopsy in confirming a MBC diagnosis. However, biopsy of a metastatic site is not required for pathologic confirmation of stage IV disease.
- Diagnosis of metastatic disease within 12 weeks prior to study enrollment.
- No symptoms of BrM or known asymptomatic BrM at study entry.
Key exclusion criteria (7 listed)
- Inability to participate in an MRI screening program as determined by the patient and/or physician. This may be on the basis of severe claustrophobia, performance status that limits additional testing, or a metal foreign body that would prevent MRI imaging.
- Inability to provide informed consent. Notably participants who require translators are allowed to enroll.
- Creatinine clearance <30 mL/min using the Cockcroft-Gault equation.
- Established need for brain imaging apart from the breast cancer diagnosis (e.g surveillance for an aneurysm).
- ECOG Performance status >2.
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 |
|---|---|---|
| MRI screeningA standard contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain will be performed at baseline, 4 months, 8 months and 12 months. | Diagnostic test | MRI screening |
Primary outcome
Proportion of eligible patients at the Sunnybrook Odette Cancer Centre (SOCC) who i) agree to enroll in the proposed randomized phase II pilot study, and ii) complete the study protocol.
Time frame: 15 months.
This outcome is intended to assess the feasibility of a future large, multi-center randomized trial.
9 secondary outcomes
Proportion of patients in the control arm who undergo imaging of the brain with CT or MRI.
Time frame: 12 months
Incidence of symptomatic brain metastases.
Time frame: Baseline, 4-, 8- and 12-months.
Number of interventions used to treat brain metastases.
Time frame: 15 months
Size and location of BrM per patient.
Time frame: At the time of diagnosis of brain metastases (from enrollment to 15 months)
Neurologic-specific quality-of-life (The Functional Assessment of Cancer Therapy-Brain; FACT-BR version 4 tool).
Time frame: Baseline, 6 months and 15 months.
Overall quality-of-life (EORTC core quality of life questionnaire; EORTC QLQ-C30 version 3 tool).
Time frame: Baseline, 6 months and 15 months.
Cancer-related anxiety (NCI PRO-CTCAE for anxiety).
Time frame: Baseline, 6 months and 15 months.
Time to death due to any cause.
Time frame: 15 months.
Time to death due to neurologic progression.
Time frame: 15 months.
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 20 Jan 2025.
- Individual participant dataSharing planned: Yes. IPD which does not include any patient identifiers will be considered but will require Research Ethics Board approval and appropriate legal contracts between collaborating institutions to ensure protection of patient data.
Related trials for Breast Neoplasm
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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. This study is not recruiting at the moment.
Katarzya J Jerzak, MD MSc FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI screening in people with Breast Neoplasm and Brain Metastases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2025. 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible patients at the Sunnybrook Odette Cancer Centre (SOCC) who i) agree to enroll in the proposed randomized phase II pilot study, and ii) complete the study protocol. (time frame: 15 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 20 Jan 2025.