Study of Screening Brain MRIs in Stage IV Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:

Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05115474
• Other study ID #: MCC-21448
• Status: Recruiting
• Start date: December 21, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Robin Dowell
• Phone: 813-745-0393
• Email: Robin.Dowell[@]moffitt.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Hormone Receptor-positive Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.

Locations

Country	Name	City	State
United States	Morton Plant Mease- Baycare	Clearwater	Florida
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Florida Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Moffitt Cancer Center Clinical Trials website