NCI’s Natural History Study of COVID-19 in CancerMay 29, 2020
From the Co-Chairs, May 2020May 29, 2020
The FEATURE study is an imaging trial for patients with bone dominant (BD) metastatic breast cancer (MBC). Co-led by Dr. Jennifer Specht (Fred Hutch/University of Washington), pictured here, left, and Dr. Heather Jacene (Dana-Farber), pictured here, right, FEATURE is evaluating whether FDG-PET/CT imaging can be used to serially measure and classify the response of bone metastases from breast cancer to systemic therapy. The study team will assess if the categories of metabolic response measured by FDG-PET/CT are predictive of key clinical endpoints: progression free survival (PFS), time to skeletal related events (SRE), and overall survival (OS).
Importantly, successful completion of FEATURE will allow for patients with BD MBC – who are often excluded from clinical trials – to participate in multicenter studies, resulting in improved outcomes and survival for patients with breast cancer. Additionally, accurate response criteria will permit discontinuation of ineffective therapies at an earlier time point, which may result in less toxicity, cost, and improved outcomes for patients who switch to more effective therapies.
Patients with BD MBC who are beginning new systemic therapy are eligible for this trial. FDG-PET/CT will be obtained at baseline, after which patients will then start new systemic therapy at the discretion of their local physician/investigator. Patients will be followed with standard of care (SOC) imaging at 12-week intervals for 4 intervals then every 24 weeks until unequivocal disease progression, up to three years after registration. FDG-PET/CT will be obtained at baseline (study-funded if completed after registration), 12 weeks after the start of systemic therapy (study-funded), and again at the time of unequivocal progression (SOC).