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

NCT ID: NCT04030507

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-26
• Study Completion Date: 2026-02-28

Brief 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).

Detailed 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.

Conditions

Breast Cancer; HER2-positive Breast Cancer; Triple Negative Breast Cancer; Hormone Receptor Positive Malignant Neoplasm of Breast; Inflammatory Breast Cancer; Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

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).

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

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

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).

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

No initial MRI screening will be conducted

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

Magnetic Resonance Imaging

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conquer Cancer Foundation

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Ayal Aizer, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayal Aizer, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ayal Aizer, MD, MHS

Role: CONTACT

aaaizer@partners.org

617-732-7560

Ivy Ricca, BA

Role: CONTACT

iricca@mgb.org

6175828927

Facility Contacts

Ayal Aizer

Role: primary

aaaizer@partners.org

617-732-7560

Other Identifiers

19-066

Identifier Type: -

Identifier Source: org_study_id