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Selective Estrogen Receptor Modulator

FES Imaging + Tamoxifen for Breast Cancer

Phase < 1

Recruiting

Led By Kari Wisinski, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

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

Must have

Estrogen receptor expression by immunohistochemistry greater than or equal to 10%

Participants with liver-only disease are not eligible

Must not have

Tamoxifen has demonstrated vaginal bleeding, birth defects and fetal loss in pregnant women

Uncontrolled intercurrent clinically significant illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing whether a new imaging technique can help optimize tamoxifen dosing for breast cancer patients with a certain type of genetic mutation.

Who is the study for?

This trial is for individuals with metastatic or unresectable breast cancer that tests positive for estrogen receptor expression and has an ESR1 mutation. They must have had prior endocrine therapy, be stable after CNS metastases treatment, and able to take oral medications. Excluded are those with liver-only disease, recent other treatments, severe allergies to similar compounds as tamoxifen or FES-PET/CT components, certain health conditions, or concurrent malignancies.

What is being tested?

The study investigates the use of FES-PET/CT imaging to measure ERα blockade in order to find the optimal dose of tamoxifen for patients with ESR1 mutations. It's a pilot study aiming at improving dosing strategies by using advanced imaging techniques on participants who may not respond well to standard doses due to these specific gene mutations.

What are the potential side effects?

Tamoxifen can cause side effects such as vaginal bleeding and increase the risk of uterine malignancy; it also poses risks during pregnancy like birth defects and fetal loss. Other potential side effects include blood clots and vision problems.

Eligibility Criteria

Inclusion Criteria

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

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My cancer tests show at least 10% estrogen receptor presence.

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My cancer has not spread to my liver only.

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I am fully active or can carry out light work.

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I have had hormone therapy for my cancer that has spread or returned within a year.

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My breast cancer cannot be removed by surgery and has spread.

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My cancer has an ESR1 mutation, confirmed by a certified test.

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My cancer is not HER2 positive.

Exclusion Criteria

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

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I am aware that Tamoxifen can cause vaginal bleeding and harm to a fetus.

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I do not have any unmanaged serious illnesses.

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My nerve damage does not severely affect my daily activities.

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I do not have severe eye conditions like advanced retinopathy or macular degeneration.

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I am allergic to medications similar to tamoxifen or [18F]-fluoroestradiol.

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I have had a blood clot or stroke in the past.

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I have no cancer other than skin cancer or cervical cancer that hasn't spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of FES Blockade at each dose level to determine the Optimal Tamoxifen Dose

Secondary study objectives

FES uptake at each dose level: SUVmax

FES uptake at each dose level: SUVmean

FES uptake at each dose level: Tumor-to-Blood Pool ratio

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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: Tamoxifen Dose LevelsExperimental Treatment2 Interventions

Three participants will be enrolled to each dose level of oral tamoxifen (n = 12) Dose Level 1 = 20 mg daily Dose Level 2 = 80 mg daily Dose Level 3 = 160 mg daily Dose Level 4 = 200 mg daily Tamoxifen should be started within 14 days of the FES-PET/CT scan, at least 24 hours after FES injection. Participants will continue tamoxifen therapy until there is radiologic or clinical evidence of progressive disease or drug intolerance.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tamoxifen

FDA approved

0 / 14Eligibility criteria met