RecruitingPhase 2NCT06260033

Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer

A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer


Sponsor

City of Hope Medical Center

Enrollment

18 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression). Currently, the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses (fractions) given over several days. This type of radiation therapy helps spare normal tissue and has been shown to improve survival. SBRT may kill more tumor cells and allow patients with oligoprogressive ER + metastatic breast cancer to continue taking current systemic treatment. This trial also tests how well ER targeted positron emission tomography (PET)/ computed tomography (CT) imaging, using FES, works in identifying progressive disease in patients with ER + metastatic breast cancer. FES, a radiolabeled substance, binds to estrogen receptors and gives off radiation that can be detected by a PET scan. The PET scan, an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, FES, forms an image that shows where tumor cells with estrogen receptors can be found in the body. CT images use x-rays to provide an exact outline of organs. FES PET/CT may improve identification of progressive disease in patients with ER + metastatic breast cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted radiation approach called stereotactic body radiation therapy (SBRT) combined with a special imaging scan (FES PET/CT) for people with estrogen receptor-positive metastatic breast cancer whose disease is progressing in only a small number of spots (called oligoprogression). The goal is to treat the progressing lesions with precise radiation while continuing the same overall systemic therapy. **You may be eligible if...** - You are 18 or older - You have ER-positive metastatic breast cancer - Only 1 to 4 lesions outside the brain are growing or are new - All progressing lesions can be safely treated with SBRT - You are in reasonably good health (ECOG score 0–2) - You can read and understand English or Spanish **You may NOT be eligible if...** - More than 4 lesions are progressing - You have malignant fluid in the chest or abdomen that is progressing - Your progressing lesions cannot be safely treated with radiation - You are pregnant - You have other serious medical conditions that prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo PET/CT scan

DRUGF-18 16 Alpha-Fluoroestradiol

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT scan

OTHERQuestionnaire Administration

Ancillary studies

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT


Locations(2)

City of Hope Medical Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

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NCT06260033


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