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Hormone Receptor Imaging for Breast Cancer

Phase 2

Waitlist Available

Led By Hannah Linden

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Breast cancer from ER+ primary that is seen on other imaging tests. Tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease.

Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer

Must not have

Pregnant or lactating. Women of childbearing potential with either a positive or no pregnancy test at baseline are excluded.

An inability to lie still for the tests

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of therapy up to 20 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at using F-18 to measure hormone receptors in breast cancer patients before, during, and after hormone therapy. This may help show how well a patient responds to treatment.

Who is the study for?

This trial is for adults with breast cancer that has been confirmed to express hormone receptors and who are about to undergo endocrine therapy. They must not have taken certain medications recently, be able to lie still for scans, and consent to treatment records access. Pregnant individuals or those with uncontrolled diabetes, recent chemotherapy, or weighing over 300 lb cannot participate.

What is being tested?

[F-18] FES PET/CT scans are being tested to see how well they measure the effect of hormone-targeted therapies on breast cancer by comparing images before, during, and after treatment. The goal is to better understand a patient's response to these therapies.

What are the potential side effects?

While the description does not specify side effects from the interventions (imaging procedures), typical risks may include exposure to radiation from PET/CT scans which can increase cancer risk over time. There might also be discomfort or allergic reactions related to contrast agents used.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is ER+ and confirmed by tests on the primary or recurrent tumor.

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I am an adult with diagnosed breast cancer, not currently pregnant.

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I stopped taking tamoxifen or similar drugs 6 weeks ago and chemotherapy 3 weeks ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, or able to become pregnant without a negative pregnancy test.

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I cannot stay still for tests.

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I do not have any serious illnesses besides my cancer.

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My blood sugar levels are not controlled and often exceed 200 mg/dL.

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I need anesthesia for PET scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of therapy up to 20 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of therapy up to 20 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of therapy up to 20 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax

F-18 16 Alpha-fluoroestradiol (FES) Uptake

Proportion of Patients With a Threshold of Percentage Change, or That Surpass a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)

Secondary study objectives

Time to Disease Progression

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 (F-18 FES PET/CT)Experimental Treatment5 Interventions

Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Fludeoxyglucose F-18

2018

Completed Phase 4

~610