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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04030507
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dana-Farber Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ayal Aizer, MD, MHS
Principal Investigator Affiliation Brigham and Women's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Inflammatory Breast Cancer, Metastatic Breast Cancer
Additional Details

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.

Arms & Interventions

Arms

Experimental: Inflammatory Breast Cancer Managed with Curative Intent

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.

Experimental: HR+ or HER2+ Metastatic Breast Cancer - Screening Arm

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 Intervention: HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm

No initial MRI screening will be conducted

Experimental: Triple Negative Breast Cancer

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

Interventions

Device: - MRI

MRI (which stands for magnetic resonance imaging) provide imaging of the brain which help look for brain metastases (spread of the breast cancer to the brain).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Ayal Aizer

[email protected]

617-732-7560

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