Trial ID:NCT04030507
Protocol #:19-066
Condition(s):Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Inflammatory Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
Phase:II
Principal Investigator:Aizer, Ayal
Site Research Nurse(s):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:
- 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
Protocol #: 19-066