This trial studies the usefulness of a screening magnetic resonance imaging (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.
Additional locations may be listed on ClinicalTrials.gov for NCT04030507.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Ayal Aaron Aizer
Phone: 617-732-7560
Dana-Farber Cancer InstituteStatus: Active
Contact: Ayal Aaron Aizer
Phone: 617-732-7560
PRIMARY OBJECTIVES:
I. To determine if screening MRI of the brain yields a lower rate of presentation with symptomatic metastases, relative to historic controls, in patients with breast cancer and extracranial metastatic disease or unresectable local recurrence.
II. 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 and 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 and interference;
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 undergo screening MRI at baseline. Patients with no brain metastases then additional screening MRIs throughout the trial until progression, up to two years.
After completion of study, patients are followed up periodically.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorAyal Aaron Aizer