Screening MRI Scan for the Imaging of Metastatic, Unresectable, or Recurrent Breast Cancer

Status: Active

Description

This trial studies the usefulness of a screening MRI scan of the brain in patients with breast cancer that has spread to other places in the body (metastatic), cannot be removed by surgery (unresectable), or has come back (recurrent). Screening MRIs of the brain may be helpful in assessing for brain involvement by breast cancer, if it has occurred.

Eligibility Criteria

Inclusion Criteria

  • Participants must have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and HER2. If subtype has changed over the course of a patient’s disease, the treating clinician and/or study principal investigator (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 have a life expectancy of greater than 12 weeks
  • Participants must be willing to undergo study procedures
  • The effects of gadolinium / other 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 (EGFR < 30) 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

Locations & Contacts

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Contact: Ayal Aaron Aizer
Phone: 617-732-7560
Email: aaaizer@partners.org
Dana-Farber Cancer Institute
Status: Active
Contact: Ayal Aaron Aizer
Phone: 617-732-7560
Email: aaaizer@partners.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine if use of screening magnetic resonance imaging (MRI) of the brain yields better neurologic quality of life in patients with HR+/HER2- and HER2+ breast cancer who initiate first-line or second-line chemotherapy for extracranial metastatic disease or unresectable local recurrence.

II. To determine if screening MRI of the brain yields a lower rate of presentation with symptomatic metastases, relative to historic controls, in patients with triple negative breast cancer (TNBC) who initiate first-line or secondline chemotherapy for extracranial metastatic disease or unresectable local recurrence.

III. To prospectively evaluate the incidence of brain metastases in patients with inflammatory breast cancer who are treated with curative intent.

SECONDARY OBJECTIVE:

I. To prospectively determine whether use of screening MRI of the brain for earlier detection of brain metastases in patients with breast cancer who are initiating first or second-line chemotherapy for extracranial metastatic disease / unresectable local recurrence impacts:

Ia. Number of brain metastases

Ib. Size of brain metastases

Ic. Brainstem involvement

Id. Leptomeningeal involvement

Ie. Radiographic appearance of brain metastases

If. Neurologic symptoms

Ig. Neurologic death

Ih. All-cause mortality

Ii. Seizures

Ij. Employment of whole brain radiation

Ik. Employment of neurosurgical resection

Il. Treatment strategy

OUTLINE: Patients are assigned to 1 of 3 groups.

GROUP I: Patients with triple negative subtype undergo screening MRI at baseline. Patients with no brain metastases then undergo a second MRI of the brain at first systemic progression after study entry.

GROUP II: Patients with inflammatory breast cancer undergo screening MRI at baseline. Patients with no brain metastases then undergo screening MRI of the brain every 6 months for 2 years and at first systemic progression.

GROUP III: Patients with HER2+ or HR+/HER2- subtype are randomized to 1 of 2 arms.

ARM I: Patients undergo screening MRI at baseline. Patients with no brain metastases then undergo a second MRI of the brain at first systemic progression after study entry.

ARM II: Patients do not undergo screening MRI.

After completion of study, patients are followed up periodically.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Screening

Lead Organization

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Ayal Aaron Aizer

Trial IDs

Primary ID 19-066
Secondary IDs NCI-2019-06114
Clinicaltrials.gov ID NCT04030507