Screening MRI of the brain in patients with metastatic breast cancer managed with first through fourth line chemotherapy or inflammatory breast cancer managed with definitive intent: A prospective study

Protocol # :
Breast Cancer
HER2-positive Breast Cancer
Triple Negative Breast Cancer
Hormone Receptor Positive Malignant Neoplasm of Breast
Inflammatory Breast Cancer
Metastatic Breast Cancer
Disease Sites
Principal Investigator
Aizer, Ayal
Site Research Nurses
Cung, Connie
Mann, Eileen, Marie
Roche, Kathleen, A.
Spicer, Beverly, A.

Trial Description

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).

Eligibility Requirements

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

- 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