Study of Screening Brain MRIs in Stage IV Breast Cancer

Conditions

HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer, Triple Negative Breast Cancer

Keywords

Stage IV Breast Cancer

Brief summary

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

Ahmed KA, Kim Y, Armaghani AJ, Arrington JA, Costa RL, Czerniecki BJ, Diaz R, Dowell RA, Extermann M, Forsyth PA, Lee KT, Loftus L, Mills MN, Phuoc VH, Rosa M, Soliman HH, Sam CS, Washington IR, Soyano AE, Han HS.

2025-07-015 citations

10.1093/neuonc/noaf018

Abstract PO3-20-05: Phase II Study of Genomically Guided Radiation Dose Personalization in the Management of Triple Negative Breast Cancer

Kamran A. Ahmed, Iman Washington, Matthew N. Mills, Michelle DeJesus, Youngchul Kim et al. (23 authors)

Cancer Research2024-05-021 citations

10.1158/1538-7445.sabcs23-po3-20-05

Abstract OT3-19-01: Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer

Kamran A. Ahmed, Youngchul Kim, Avan Armaghani, John A. Arrington, Ricardo Costa et al. (16 authors)

Cancer Research2023-03-01

10.1158/1538-7445.sabcs22-ot3-19-01

Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging

Participants will undergo MRI imaging with and without contrast.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status * Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients * Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients * Age ≥ 18 * Life expectancy ≥ 6 months * Eastern Cooperative Oncology Group performance status 0 to 2 * Patients must be able to understand and the willingness to sign an informed consent for study procedures * Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion criteria

* Prior diagnosis or treatment of brain metastases or leptomeningeal disease * Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years * Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment * Indications warranting brain MRI for other neurologic conditions at time of study entry * Contraindication towards MRI imaging with contrast * Chronic kidney disease stage IV or V or end stage renal disease

Design outcomes

Primary

Measure	Time frame	Description
Rate of Brain Metastasis	at Baseline	Rate of brain metastasis by breast cancer subtype at baseline using MRI images.

Secondary

Measure	Time frame	Description
Rate of Asymptomatic Leptomeningeal Disease	Baseline and at up to 6 months	Rate of asymptomatic leptomeningeal disease by breast cancer subtype at baseline and at 6 months or first systemic progression, using MRI images.
Number of Brain Metastases	Baseline	Number of Brain Metastases at Diagnosis by Breast Cancer Subtype, using MRI images.
Overall Survival	Up to 6 months	Overall Survival (OS) will be measured from the initial on study date to the recorded date of death.
Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation	Up to 6 months	Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation by breast cancer type.
Brain Metastasis Specific Survival	Up to 6 months	Brain metastasis specific survival following brain metastasis by breast cancer subtype

Countries

United States

Contacts

CONTACTRobin Dowell

Robin.Dowell@moffitt.org813-745-0393

PRINCIPAL_INVESTIGATORKamran A Ahmed, MD

Moffitt Cancer Center

Outcome results

None listed