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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06260033
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Estrogen Receptor-Positive Breast Carcinoma
  • Metastatic Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo PET/CT scan
  • F-18 16 Alpha-Fluoroestradiol — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT scan
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT

Study Details

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.

Key Dates

Start date
Jul 23, 2024
Status verified
Oct 2025
Primary completion
Oct 29, 2026
Completion
Oct 29, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (SBRT, FES PET/CT)
    Patients currently taking SERMs/ SERDs immediately undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of \> 4 sites of disease progression. Patients not currently taking SERMs/SERDs first receive F-FES IV and undergo PET/CT scans at baseline. After baseline FES PET/CT, patients with ≤ 4 sites of progressive disease then undergo 3 or 5 treatment fractions of SBRT within 3 weeks in the absence of unacceptable toxicity or evidence of \> 4 sites of disease progression. All patients undergo FES PET/CT at 12 and 24 weeks. Patients with SD after 12 or 24 week FES PET/CT may continue standard systemic therapy. Patients with ≤ 4 sites of progressive disease after 12 or 24 week FES PET/CT may receive SBRT to additional sites in the absence of unacceptable toxicity or evidence of \> 4 sites of disease progression. All patients also undergo CT, PET/CT, or bone scans, and blood samples collection during screening and on study.

Primary Outcome Measure

Proportion of patients that remain on their original systemic therapy for at least ≥ 24 weeks post stereotactic body radiation therapy (SBRT) treatment [ Time Frame: Up to 24 weeks post SBRT treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Jose G. Bazan
[email protected]
626-505-7901
Jose G. Bazan (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Jose G. Bazan
[email protected]
626-505-7901
Jose G. Bazan (PRINCIPAL_INVESTIGATOR)

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