Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer

Not Applicable

Recruiting

• Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast; Metastatic Breast Cancer; HER2-positive Breast Cancer; Breast Cancer; Triple Negative Breast Cancer; Inflammatory Breast Cancer
• Interventions: Device: MRI

• Registration Number: NCT04030507
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-24
• Study Start: 2019-07-26
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HR+ or HER2+ Metastatic Breast Cancer - Screening Arm	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
Inflammatory Breast Cancer Managed with Curative Intent	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.
Triple Negative Breast Cancer	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

Primary Outcome Measures

Name	Time	Method
Incidence of Brain Metastases	Through study completion, an average of 1 year	For patients with inflammatory breast cancer managed with curative intent
Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module	12 Months	For patients with HR+/HER2- or HER2+ metastatic breast cancer
Incidence of Symptomatic Brain Metastases	Through study completion, an average of 1 year	For patients with triple negative metastatic breast cancer

Secondary Outcome Measures

Name	Time	Method
Receipt of neurosurgical resection due to brain metastases	Through study completion, an average of 1 year
Number of brain metastases	Through study completion, an average of 1 year
Size of brain metastases	Through study completion, an average of 1 year
Neurocognitive function using the Controlled Oral Word Association Test	Through study completion, an average of 1 year
Neurocognitive function using the Mini-Mental Status Exam Instrument	Through study completion, an average of 1 year
Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain	Through study completion, an average of 1 year
Development of seizures based on review of medical notes / history	Through study completion, an average of 1 year
Receipt of whole brain radiation due to brain metastases	Through study completion, an average of 1 year
Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain	Through study completion, an average of 1 year
Development of symptomatic brain metastases based on review of medical notes / history	Through study completion, an average of 1 year
Neurologic death	Through study completion, an average of 1 year
Radiographic appearance of brain metastases	Through study completion, an average of 1 year
All-cause mortality	Through study completion, an average of 1 year
Quality of life assessment via EuroQol Group 5D Instrument	Through study completion, an average of 1 year
Neurocognitive function using the Hopkins Verbal Learning Test Instrument	Through study completion, an average of 1 year
Neurocognitive function using the Trail Making Test Instrument	Through study completion, an average of 1 year

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States