Clinical trial NCT04030507: 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
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Conquer Cancer Foundation
First posted: 2019-07-24
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module
timeFrame: 12 Months
measure: Incidence of Symptomatic Brain Metastases
timeFrame: Through study completion, an average of 1 year
measure: Incidence of Brain Metastases
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Number of brain metastases
timeFrame: Through study completion, an average of 1 year
measure: Size of brain metastases
timeFrame: Through study completion, an average of 1 year
measure: Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain
timeFrame: Through study completion, an average of 1 year
measure: Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain
timeFrame: Through study completion, an average of 1 year
measure: Radiographic appearance of brain metastases
timeFrame: Through study completion, an average of 1 year
measure: Development of symptomatic brain metastases based on review of medical notes / history
timeFrame: Through study completion, an average of 1 year
measure: Neurologic death
timeFrame: Through study completion, an average of 1 year
measure: All-cause mortality
timeFrame: Through study completion, an average of 1 year
measure: Development of seizures based on review of medical notes / history
timeFrame: Through study completion, an average of 1 year
measure: Receipt of whole brain radiation due to brain metastases
timeFrame: Through study completion, an average of 1 year
measure: Receipt of neurosurgical resection due to brain metastases
timeFrame: Through study completion, an average of 1 year
measure: Quality of life assessment via EuroQol Group 5D Instrument
timeFrame: Through study completion, an average of 1 year
measure: Neurocognitive function using the Hopkins Verbal Learning Test Instrument
timeFrame: Through study completion, an average of 1 year
measure: Neurocognitive function using the Trail Making Test Instrument
timeFrame: Through study completion, an average of 1 year
measure: Neurocognitive function using the Controlled Oral Word Association Test
timeFrame: Through study completion, an average of 1 year
measure: Neurocognitive function using the Mini-Mental Status Exam Instrument
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Ayal Aizer, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: