Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
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
Experimental
Experimental
No Intervention
Experimental
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
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