MRI for Inflammatory Breast Cancer (IBC)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Inflammatory Breast Cancer (IBC)+9 More
MRI - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing if MRI can find brain metastases in people with breast cancer.

Eligible Conditions
  • Inflammatory Breast Cancer (IBC)
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Breast
  • Malignant Neoplasms
  • Breast Cancer
  • erbB-2 Receptor

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 16 Secondary · Reporting Duration: Through study completion, an average of 1 year

12 Months
Neurologic Quality of Life at 12 Months using the MD Anderson Symptom Inventory - Brain Tumor Module
Year 1
All-cause mortality
Development of leptomeningeal carcinomatosis as seen on magnetic resonance imaging of the brain
Development of metastases in the brainstem as seen on magnetic resonance imaging of the brain
Development of seizures based on review of medical notes / history
Development of symptomatic brain metastases based on review of medical notes / history
Incidence of Brain Metastases
Incidence of Symptomatic Brain Metastases
Neurocognitive function using the Controlled Oral Word Association Test
Neurocognitive function using the Hopkins Verbal Learning Test Instrument
Neurocognitive function using the Mini-Mental Status Exam Instrument
Neurocognitive function using the Trail Making Test Instrument
Neurologic death
Number of brain metastases
Quality of life assessment via EuroQol Group 5D Instrument
Radiographic appearance of brain metastases
Receipt of neurosurgical resection due to brain metastases
Brain
Size of brain metastases

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm
1 of 4
Triple Negative Breast Cancer
1 of 4
Inflammatory Breast Cancer Managed with Curative Intent
1 of 4
HR+ or HER2+ Metastatic Breast Cancer - Screening Arm
1 of 4
Active Control
Experimental Treatment

214 Total Participants · 4 Treatment Groups

Primary Treatment: MRI · No Placebo Group · N/A

Triple Negative Breast Cancer
Device
Experimental Group · 1 Intervention: MRI · Intervention Types: Device
Inflammatory Breast Cancer Managed with Curative Intent
Device
Experimental Group · 1 Intervention: MRI · Intervention Types: Device
HR+ or HER2+ Metastatic Breast Cancer - Screening Arm
Device
Experimental Group · 1 Intervention: MRI · Intervention Types: Device
HR+ or HER2+ Metastatic Breast Cancer - No Screening ArmNoIntervention Group · 1 Intervention: HR+ or HER2+ Metastatic Breast Cancer - No Screening Arm · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

Conquer Cancer FoundationOTHER
11 Previous Clinical Trials
1,034 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,012 Previous Clinical Trials
393,145 Total Patients Enrolled
3 Trials studying Inflammatory Breast Cancer (IBC)
95 Patients Enrolled for Inflammatory Breast Cancer (IBC)
Ayal Aizer, MD, MHSPrincipal Investigator - Brigham and Women's Hospital
Brigham & Women's Hospital, Brigham and Women's Physicians Organization, Dana-Farber Cancer Institute
Yale University School Of Medicine (Medical School)
1 Previous Clinical Trials
112 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have histologically or cytologically confirmed breast cancer with pathologic assessment of estrogen receptor (ER), progesterone receptor (PR), and (human epidermal growth factor receptor 2 (HER2) status.
You have a life expectancy of greater than 12 weeks.
Participants must be able to understand and sign a written informed consent document.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: October 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.