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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    214
  • sponsor
    Dana-Farber Cancer Institute
Updated on 18 February 2022
cancer
estrogen
breast cancer
growth factor
MRI
progesterone
metastasis
epidermal growth factor receptor
HER2
EGFR
brain metastases
human epidermal growth factor
progesterone receptor
erbb2
epidermal growth factor
estrogen receptor
inflammatory breast cancer
recurrent breast cancer
her1

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).

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.

Details
Condition Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Inflammatory Breast Cancer, Metastatic Breast Cancer
Treatment MRI
Clinical Study IdentifierNCT04030507
SponsorDana-Farber Cancer Institute
Last Modified on18 February 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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