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FES PET/CT Imaging for Predicting Treatment Response in Breast Cancer

Phase 2

Waitlist Available

Led By Farrokh Dehdashti

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease may be measurable (by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) or non-measurable but must be present in at least one non-liver site, where presence is defined as 1.5 cm or greater and visualized on PET/CT with [18F]-fluorodeoxyglucose (FDG); patients with effusion only disease or disease only in the liver are not eligible for the study

Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study using F-18 16 alpha-fluoroestradiol positron emission tomography/computed tomography to see if it can help predict response to endocrine therapy in patients with newly diagnosed breast cancer.

Who is the study for?

This trial is for postmenopausal women, men, or premenopausal women planning to receive standard endocrine therapy for newly diagnosed metastatic breast cancer that's estrogen-receptor positive. Participants must have a life expectancy over 6 months, be able to lie still for PET/CT scans, and not have received prior endocrine therapy for metastatic disease. They should not be in liver failure or have had more than one line of chemotherapy for metastatic disease.

What is being tested?

The study tests if F-18 16 alpha-fluoroestradiol (FES) PET/CT can predict the response of metastatic breast cancer to endocrine therapy. FES is a radioactive hormone that highlights cancer in the body during imaging procedures, potentially helping doctors anticipate treatment effectiveness.

What are the potential side effects?

As this trial focuses on diagnostic procedures rather than drug treatments, side effects are minimal but may include discomfort from lying still during scans and exposure to radiation typical of PET/CT imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be seen on scans and is not only in my liver.

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I have no allergies to compounds similar to 18F-FES.

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My breast cancer has spread and was confirmed by a tissue test.

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I can stay still for up to 30 minutes.

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I am not planning to receive targeted or HER2 therapy along with hormone therapy.

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My cancer is not HER2 positive.

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I am using or willing to use effective birth control during the study.

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I have not had hormone therapy for my advanced cancer.

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I am postmenopausal, a man, or premenopausal and planned for standard hormone therapy after a specific scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Negative predictive value of 18F FES uptake for response (CB), defined as the proportion of patients with a negative FES test result who have progressive disease

Secondary study objectives

FES SUVmax

FES SUVmax < 1.5 as the optimal cutpoint for predicting PFS

FES uptake, as measured by SUVmax and semi-quantitative ER from IHC

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (FES PET/CT)Experimental Treatment4 Interventions

Between 0 to 30 days before start of endocrine therapy, patients receive F-18 16 alpha-fluoroestradiol IV over 2 minutes and undergo PET/CT. Patients may undergo a second FES-PET/CT study at least 24 hours after the first study and no later than 10 days after the initial study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Positron Emission Tomography

2011

Completed Phase 2

~2200