Breast CancerNCT04030507
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
A study testing MRI in people with Breast Cancer and HER2-positive Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2019to Feb 2028
- 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
- Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and/or study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment.
- Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic/recurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis.
- Participants must be age 18 years or older.
- Participants must have a life expectancy of greater than 12 weeks.
- Participants must be willing to undergo study procedures.
- The effects of gadolinium / other magnetic resonance imaging (MRI)-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
- Participants must possess the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).
- Participants who have chronic kidney disease stage IV-V or end stage renal disease.
- Participants with a history of anaphylactic reactions to gadolinium.
- Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
- Patients with a prior diagnosis of brain metastases
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First/Second Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study
This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials examine the safety and effectiveness of an investigational intervention, in this case magnetic resonance imaging (MRI) of the brain, to learn whether it is helpful in managing a specific disease.
In this research study, the investigators are utilizing screening MRIs of the brain to evaluate breast cancer patients for metastases to the brain. The investigators hope to understand whether screening MRIs of the brain can be implemented into the standard of care to earlier detect brain metastases in a population where screening MRIs of the brain are not currently recommended or systematically performed.
This trial will contain 4 cohorts:
- Those with triple negative breast cancer (TNBC) will undergo screening MRI of the brain as part of a single arm, non-comparative study
2+3. Those with hormone receptor positive/(human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) and HER2 positive (HER2+) subtypes will be randomized to receipt of screening MRI of the brain or no screening MRI of the brain to definitively test the value of MRI screening.
- Patients with inflammatory breast cancer being treated with curative intent will undergo screening MRI of the brain as part of a single arm, non-comparative study.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Inflammatory Breast Cancer, Metastatic Breast Cancer
- Being tested
- MRI
- Keywords
- Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Inflammatory Breast Cancer, Metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called Magnetic Resonance Imaging
MRI (which stands for magnetic resonance imaging) provide imaging of the brain which help look for brain metastases (spread of the breast cancer to the brain).
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Breast Cancer Managed with Curative Intent | Experimental | * Patients will receive an initial screening magnetic resonance imaging (MRI) of the brain
* If no evidence of intracranial involvement is identified, additional screening MRIs of the brain every six months for two years and at initial systemic progression. Receives: Device: MRI |
| HR+ or HER2+ Metastatic Breast Cancer - Screening Arm | Experimental | * An initial MRI screening will be conducted
* If negative, patients will receive a second MRI of the brain at first systemic progression after study entry Receives: Device: MRI |
| HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm | No intervention | No initial MRI screening will be conducted |
| Triple Negative Breast Cancer | Experimental | * An initial MRI screening will be conducted
* If negative, patients will receive a second MRI of the brain at first systemic progression after study entry Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module
For patients with HR+/HER2- or HER2+ metastatic breast cancer
Measured: 12 Months
Incidence of Symptomatic Brain Metastases
For patients with triple negative metastatic breast cancer
Measured: Through study completion, an average of 1 year
Incidence of Brain Metastases
For patients with inflammatory breast cancer managed with curative intent
Measured: Through study completion, an average of 1 year
Secondary outcomes (16)
Number of brain metastases
Measured: Through study completion, an average of 1 year
Size of brain metastases
Measured: Through study completion, an average of 1 year
Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain
Measured: Through study completion, an average of 1 year
Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain
Measured: Through study completion, an average of 1 year
Radiographic appearance of brain metastases
Measured: Through study completion, an average of 1 year
Development of symptomatic brain metastases based on review of medical notes / history
Measured: Through study completion, an average of 1 year
Neurologic death
Measured: Through study completion, an average of 1 year
All-cause mortality
Measured: Through study completion, an average of 1 year
Development of seizures based on review of medical notes / history
Measured: Through study completion, an average of 1 year
Receipt of whole brain radiation due to brain metastases
Measured: Through study completion, an average of 1 year
Receipt of neurosurgical resection due to brain metastases
Measured: Through study completion, an average of 1 year
Quality of life assessment via EuroQol Group 5D Instrument
Measured: Through study completion, an average of 1 year
Neurocognitive function using the Hopkins Verbal Learning Test Instrument
Measured: Through study completion, an average of 1 year
Neurocognitive function using the Trail Making Test Instrument
Measured: Through study completion, an average of 1 year
Neurocognitive function using the Controlled Oral Word Association Test
Measured: Through study completion, an average of 1 year
Neurocognitive function using the Mini-Mental Status Exam Instrument
Measured: Through 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 posted24 Jul 2019
- Study start26 Jul 2019
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Conquer Cancer Foundation, Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Ayal A. Aizer, MD, Brigham and Women's Hospital
- Investigators
- Ayal Aizer, MD, MHS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030507
- Sponsor's protocol ID
- 19-066
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2019
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Magnetic Resonance Imaging of the Brain in Patients With Metastatic Breast Cancer Managed With First/Second Line Chemotherapy or Inflammatory Breast Cancer Managed With Definitive Intent: A Prospective Study
- ClinicalTrials.gov ID
- NCT04030507
- Acronym / sponsor ID
- 19-066
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Inflammatory Breast Cancer, Metastatic Breast Cancer
- Keywords
- Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Inflammatory Breast Cancer, Metastatic breast cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Conquer Cancer Foundation, Dana-Farber Cancer Institute
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 24 Jul 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.
This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials examine the safety and effectiveness of an investigational intervention, in this case magnetic resonance imaging (MRI) of the brain, to learn whether it is helpful in managing a specific disease.
In this research study, the investigators are utilizing screening MRIs of the brain to evaluate breast cancer patients for metastases to the brain. The investigators hope to understand whether screening MRIs of the brain can be implemented into the standard of care to earlier detect brain metastases in a population where screening MRIs of the brain are not currently recommended or systematically performed.
This trial will contain 4 cohorts:
- Those with triple negative breast cancer (TNBC) will undergo screening MRI of the brain as part of a single arm, non-comparative study
2+3. Those with hormone receptor positive/(human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) and HER2 positive (HER2+) subtypes will be randomized to receipt of screening MRI of the brain or no screening MRI of the brain to definitively test the value of MRI screening.
- Patients with inflammatory breast cancer being treated with curative intent will undergo screening MRI of the brain as part of a single arm, non-comparative study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Breast Cancer Managed with Curative Intent | Experimental | Device: MRI* Patients will receive an initial screening magnetic resonance imaging (MRI) of the brain * If no evidence of intracranial involvement is identified, additional screening MRIs of the brain every six months for two years and at initial systemic progression. |
| HR+ or HER2+ Metastatic Breast Cancer - Screening Arm | Experimental | Device: MRI* An initial MRI screening will be conducted * If negative, patients will receive a second MRI of the brain at first systemic progression after study entry |
| HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm | No intervention | –No initial MRI screening will be conducted |
| Triple Negative Breast Cancer | Experimental | Device: MRI* An initial MRI screening will be conducted * If negative, patients will receive a second MRI of the brain at first systemic progression after study entry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status. If subtype has changed over the course of a patient's disease, the treating clinician and/or study PI is responsible for selecting the subtype that most likely reflects the preponderance of oncologic disease at the time of enrollment.
- Participants must have radiographic evidence of extracranial, distant metastases or unresectable, locally recurrent breast cancer and be initiating (within 8 weeks of registration) first-line or second-line chemotherapy for their metastatic/recurrent disease OR inflammatory breast cancer being managed with curative intent within six months of diagnosis.
- Participants must be age 18 years or older.
- Participants must have a life expectancy of greater than 12 weeks.
- Participants must be willing to undergo study procedures.
Key exclusion criteria (5 listed)
- Participants who have a contraindication to MRI (e.g. noncompatible implanted metallic device for which MRI is absolutely contraindicated).
- Participants who have chronic kidney disease stage IV-V or end stage renal disease.
- Participants with a history of anaphylactic reactions to gadolinium.
- Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
- Patients with a prior diagnosis of brain metastases
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 |
|---|---|---|
| MRIAlso: Magnetic Resonance ImagingMRI (which stands for magnetic resonance imaging) provide imaging of the brain which help look for brain metastases (spread of the breast cancer to the brain). | Device | HR+ or HER2+ Metastatic Breast Cancer - Screening Arm, Inflammatory Breast Cancer Managed with Curative Intent, Triple Negative Breast Cancer |
Primary outcome
Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module
Time frame: 12 Months
For patients with HR+/HER2- or HER2+ metastatic breast cancer
Incidence of Symptomatic Brain Metastases
Time frame: Through study completion, an average of 1 year
For patients with triple negative metastatic breast cancer
Incidence of Brain Metastases
Time frame: Through study completion, an average of 1 year
For patients with inflammatory breast cancer managed with curative intent
16 secondary outcomes
Number of brain metastases
Time frame: Through study completion, an average of 1 year
Size of brain metastases
Time frame: Through study completion, an average of 1 year
Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain
Time frame: Through study completion, an average of 1 year
Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain
Time frame: Through study completion, an average of 1 year
Radiographic appearance of brain metastases
Time frame: Through study completion, an average of 1 year
Development of symptomatic brain metastases based on review of medical notes / history
Time frame: Through study completion, an average of 1 year
Neurologic death
Time frame: Through study completion, an average of 1 year
All-cause mortality
Time frame: Through study completion, an average of 1 year
Development of seizures based on review of medical notes / history
Time frame: Through study completion, an average of 1 year
Receipt of whole brain radiation due to brain metastases
Time frame: Through study completion, an average of 1 year
Receipt of neurosurgical resection due to brain metastases
Time frame: Through study completion, an average of 1 year
Quality of life assessment via EuroQol Group 5D Instrument
Time frame: Through study completion, an average of 1 year
Neurocognitive function using the Hopkins Verbal Learning Test Instrument
Time frame: Through study completion, an average of 1 year
Neurocognitive function using the Trail Making Test Instrument
Time frame: Through study completion, an average of 1 year
Neurocognitive function using the Controlled Oral Word Association Test
Time frame: Through study completion, an average of 1 year
Neurocognitive function using the Mini-Mental Status Exam Instrument
Time frame: Through 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 9 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Ayal Aizer, MD, MHS principal investigator
Brigham and Women's Hospital
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 in people with Breast Cancer and HER2-positive Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.
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 5 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 9 Sep 2026. 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 United States. 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?
Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module (time frame: 12 Months). The study lists 3 primary outcomes in all. 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 9 Sep 2026.