Back to resultsScreening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
Primary Purpose
Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Inflammatory Breast Cancer, Metastatic breast cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
Experimental
Arm Label
Inflammatory Breast Cancer Managed with Curative Intent
HR+ or HER2+ Metastatic Breast Cancer - Screening Arm
HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm
Triple Negative Breast Cancer
Arm Description
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.
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
No initial MRI screening will be conducted
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
Outcomes
Primary Outcome Measures
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
Incidence of Symptomatic Brain Metastases
For patients with triple negative metastatic breast cancer
Incidence of Brain Metastases
For patients with inflammatory breast cancer managed with curative intent
Secondary Outcome Measures
Number of brain metastases
Size of brain metastases
Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain
Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain
Radiographic appearance of brain metastases
Development of symptomatic brain metastases based on review of medical notes / history
Neurologic death
All-cause mortality
Development of seizures based on review of medical notes / history
Receipt of whole brain radiation due to brain metastases
Receipt of neurosurgical resection due to brain metastases
Quality of life assessment via EuroQol Group 5D Instrument
Neurocognitive function using the Hopkins Verbal Learning Test Instrument
Neurocognitive function using the Trail Making Test Instrument
Neurocognitive function using the Controlled Oral Word Association Test
Neurocognitive function using the Mini-Mental Status Exam Instrument
Full Information
NCT ID
NCT04030507
First Posted
July 19, 2019
Last Updated
September 21, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Conquer Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04030507
Brief Title
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Conquer Cancer Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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:
1. 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.
4. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inflammatory Breast Cancer Managed with Curative Intent
Arm Type
Experimental
Arm Description
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.
Arm Title
HR+ or HER2+ Metastatic Breast Cancer - Screening Arm
Arm Type
Experimental
Arm Description
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
Arm Title
HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm
Arm Type
No Intervention
Arm Description
No initial MRI screening will be conducted
Arm Title
Triple Negative Breast Cancer
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
MRI
Other Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
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).
Primary Outcome Measure Information:
Title
Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module
Description
For patients with HR+/HER2- or HER2+ metastatic breast cancer
Time Frame
12 Months
Title
Incidence of Symptomatic Brain Metastases
Description
For patients with triple negative metastatic breast cancer
Time Frame
Through study completion, an average of 1 year
Title
Incidence of Brain Metastases
Description
For patients with inflammatory breast cancer managed with curative intent
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Number of brain metastases
Time Frame
Through study completion, an average of 1 year
Title
Size of brain metastases
Time Frame
Through study completion, an average of 1 year
Title
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
Title
Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain
Time Frame
Through study completion, an average of 1 year
Title
Radiographic appearance of brain metastases
Time Frame
Through study completion, an average of 1 year
Title
Development of symptomatic brain metastases based on review of medical notes / history
Time Frame
Through study completion, an average of 1 year
Title
Neurologic death
Time Frame
Through study completion, an average of 1 year
Title
All-cause mortality
Time Frame
Through study completion, an average of 1 year
Title
Development of seizures based on review of medical notes / history
Time Frame
Through study completion, an average of 1 year
Title
Receipt of whole brain radiation due to brain metastases
Time Frame
Through study completion, an average of 1 year
Title
Receipt of neurosurgical resection due to brain metastases
Time Frame
Through study completion, an average of 1 year
Title
Quality of life assessment via EuroQol Group 5D Instrument
Time Frame
Through study completion, an average of 1 year
Title
Neurocognitive function using the Hopkins Verbal Learning Test Instrument
Time Frame
Through study completion, an average of 1 year
Title
Neurocognitive function using the Trail Making Test Instrument
Time Frame
Through study completion, an average of 1 year
Title
Neurocognitive function using the Controlled Oral Word Association Test
Time Frame
Through study completion, an average of 1 year
Title
Neurocognitive function using the Mini-Mental Status Exam Instrument
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayal Aizer, MD, MHS
Phone
617-732-7560
Email
aaaizer@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ivy Ricca, BA
Phone
6175828927
Email
iricca@mgb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayal Aizer, MD, MHS
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayal Aizer
Phone
617-732-7560
Email
aaaizer@partners.org
First Name & Middle Initial & Last Name & Degree
Ayal Aizer, MD, MHS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Learn more about this trial
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
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