Screening MRI Scan for the Imaging of Metastatic, Unresectable, or Recurrent Breast Cancer
- 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
- 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
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.
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
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 Phase NA
Trial Type Screening
Dana-Farber Harvard Cancer Center
Ayal Aaron Aizer
- Primary ID 19-066
- Secondary IDs NCI-2019-06114
- Clinicaltrials.gov ID NCT04030507