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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


Trial ID:NCT04030507

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Protocol #:19-066

877-DF-TRIAL (877-338-7425)

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


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

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