Study on Using Targeted Radiation and Special Imaging for Treating Estrogen Receptor Positive Metastatic Breast Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06260033

Provider View

This clinical trial is exploring whether a precise form of radiation therapy, combined with a special imaging technique, can help manage breast cancer that has spread and is showing limited progression. The study aims to see if this approach allows patients to continue their current treatments longer.

Patient Parameters

Program Overview

This study is testing a precise radiation treatment called stereotactic body radiation therapy (SBRT) for patients with estrogen receptor positive (ER+) breast cancer that has spread to other parts of the body and is showing limited progression. SBRT uses focused radiation to target tumors while sparing healthy tissue, potentially allowing patients to stay on their current treatments longer. The trial also examines a special imaging method, FES PET/CT, which uses a radiolabeled substance to detect cancer cells with estrogen receptors, helping to identify areas of disease progression more accurately.

Description

PRIMARY OBJECTIVE:

  • To find out if using SBRT on specific cancer spots allows patients with ER+ breast cancer to continue their current treatment for at least 24 weeks after SBRT.

SECONDARY OBJECTIVES:

  • To monitor any side effects experienced by patients receiving SBRT.
  • To see if FES-PET imaging finds more cancer spots before SBRT.
  • To assess how SBRT affects patients' quality of life.
  • To estimate how long patients can go before needing a new treatment after receiving SBRT.
  • To estimate how long patients remain free from disease progression after SBRT.

EXPLORATORY OBJECTIVES:

  • To see if FES-PET finds more cancer spots after SBRT.
  • To track changes in tumor DNA in the blood over time after SBRT.
  • To identify factors that might predict how well patients respond to SBRT.

OUTLINE:

Patients already on certain hormone therapies will receive 3 to 5 sessions of SBRT over 3 weeks, unless there are unacceptable side effects or more than 4 areas of disease progression. Patients not on these therapies will first receive a special imaging scan (FES PET/CT) to identify cancer spots. If they have 4 or fewer progressing areas, they will also receive SBRT. All patients will have follow-up imaging at 12 and 24 weeks. If the disease is stable, they may continue their current treatment. If there are 4 or fewer progressing areas, they may receive additional SBRT. Patients will also have regular scans and blood tests during the study. After completing the study, patients will have a follow-up visit 30 days later.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Can be male or female.
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Must be able to read and understand English or Spanish for questionnaires.
  • Must have confirmed ER+ metastatic breast cancer.
  • Must have 1 to 4 progressing cancer spots, not including certain conditions like fluid buildup or widespread abdominal cancer.
  • Must have cancer spots that can be safely targeted with SBRT.
  • Must not have progressing brain disease.
  • Must have cancer spots that can receive a specific dose of radiation.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for one month after.
  • Men and women must agree to use birth control or abstain from sex during the study and for one month after.

Exclusion Criteria

  • Must not have received more than three lines of treatment for metastatic disease.
  • Must not have received certain cancer treatments within 7-14 days before starting the study.
  • Must not have uncontrolled illness that makes them unsuitable for treatment.
  • Must not have other active cancers, except for certain low-risk types.
  • Must not have only liver metastases.
  • Women must not be pregnant or breastfeeding.
  • Must not have any condition that would make participation unsafe.
  • Must be able to comply with all study procedures.

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