Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06260033

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

Led by City of Hope Medical Center · Updated on 2025-10-06

18

Participants Needed

2

Research Sites

118 weeks

Total Duration

On this page

Sponsors

C

City of Hope Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent by participant or legal representative
  • Age 18 years or older
  • Female or male
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Ability to read and understand English or Spanish for questionnaires
  • Histologically confirmed estrogen receptor positive metastatic breast cancer
  • Disease progression in 1 to 4 lesions (including new lesions), with breast and/or ipsilateral axilla progression counted as one site
  • No more than 4 progressing lesions; no current progression of malignant pleural effusions, malignant ascites, abdominal carcinomatosis, or lymphangitic pulmonary involvement
  • Feasibility of SBRT for all progressing lesions, including distinct lesion borders and safe distance from critical structures
  • Patients with stable treated brain metastases allowed; no active intracranial progression or leptomeningeal disease
  • All progressing lesions suitable for SBRT dose of 30 to 40 Gy in 3 to 5 fractions
  • Negative pregnancy test for women of childbearing potential
  • Agreement to use effective birth control or abstain from heterosexual activity during study and for at least one month after last treatment for participants of childbearing potential
Not Eligible

You will not qualify if you...

  • Have received more than three lines of systemic therapy for metastatic disease
  • Received chemotherapy, radiation, biological therapy, immunotherapy, or other anti-cancer treatment within 7 to 14 days before starting SBRT (except ongoing hormone therapy)
  • Clinically significant uncontrolled illness preventing systemic therapy
  • Prior or concurrent malignancy requiring treatment except low-risk cancers like cervical carcinoma in situ, non-melanoma skin cancer, and low-grade localized prostate cancer without recurrence
  • Only liver metastases present
  • Pregnant or breastfeeding females
  • Any condition deemed unsafe for study participation by the investigator
  • Inability to comply with all study procedures as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 2 locations

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

2

City of Hope at Irvine Lennar

Irvine, California, United States, 92618

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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