SBRT and FES PET/CT for Metastatic ER+ Breast Cancer
This study is for patients with estrogen receptor-positive (ER+) breast cancer that has spread to other parts of the body (metastatic) and has shown limited progression (oligoprogression). The study will test if using Stereotactic Body Radiation Therapy (SBRT), a focused type of radiation, on these progressing areas allows you to stay on your current cancer medication for at least 24 weeks. Researchers will also use F-18 16 Alpha-Fluoroestradiol (FES) PET/CT scans to find more cancer spots. You may be able to join if you are 18 or older, have ER+ breast cancer, and meet other health criteria. The main goal is to see how many patients can continue their original treatment after SBRT.
- Study design
- This is an interventional study with a planned enrollment of 18 participants. The phase of the study is not specified.
- What's involved
- Participants will undergo blood sample collection, bone scans, and PET/CT scans, including those with F-18 16 Alpha-Fluoroestradiol (FES) given intravenously (IV).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured up to 24 weeks post SBRT treatment.
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NCT06260033
Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~18 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone ScanComputed TomographyF-18 16 Alpha-FluoroestradiolPositron Emission TomographyQuestionnaire Administration
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients that remain on their original systemic therapy for at least ≥ 24 weeks post stereotactic body radiation therapy (SBRT) treatment
Measured over Up to 24 weeks post SBRT treatment
Conditions
Where it's being run
2 sites across 1 statesCalifornia2
Study leadership
- Jose G Bazan · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative
Age: ≥ 18 years
Female or male
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Ability to read and understand English or Spanish for questionnaires
Histologically confirmed ER+ (any progesterone receptor \[PR\] and human epidermal growth factor receptor 2 \[HER2\] status is allowed) metastatic breast cancer
The presence of metastatic breast cancer at the time of study entry with progression in 1-4 lesions (including new lesions). Patients that have disease progression in the breast and/or ipsilateral axilla will be considered to have only 1 site of progression even if multiple nodules/lymph nodes are present. Patients with progression in \> 4 lesions are not allowed. Patients with current progression of malignant pleural effusions, malignant ascites, abdominal carcinomatosis, and/or lymphangitic pulmonary involvement are considered to have \> 4 metastases (Note that patients with a history of these conditions earlier in the disease course with no evidence of progression of these conditions are eligible.)
Evidence of extracranial disease progression in 1-4 discrete lesions will be defined by either of the following:
Progression of disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or PET Response Criteria in Solid Tumors (PERCIST) v 1.0 criteria OR
Progression of disease in at least 1 but up to 4 lesions as determined by the patient's treating oncologists such that the treating oncologist recommends changing to the next line systemic therapy. Note that a patient may not technically meet RECIST v 1.1 criteria for disease progression in this setting
SBRT must be feasible for all progressing lesions. Feasibility includes but is not limited to:
All progressing lesions must have distinct borders AND
Progressing lesions may not be located within 3 cm of previously irradiated critical structures such as the spinal cord, brachial plexus, brainstem, stomach, and/or small/large bowel that would render the metastasis unsafe to target with SBRT per the treating radiation oncologist
Patients with prior treated brain metastases that are stable are allowed. Patients must not have intracranial disease progression. Patients with prior or current leptomeningeal disease are not allowed
All progressing lesions must be amenable to stereotactic body radiation therapy to a dose of 30 Gy to 40 Gy in 3 to 5 fractions per the treating radiation oncologist
Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test, If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy.
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion
Has received at least one line, but not more than three lines, of systemic therapy for metastatic disease
Patients may not have received chemotherapy, radiation therapy, biological therapy, immunotherapy, or other anti-cancer treatment within 7-14 days of the start of study therapy (SBRT) at the discretion of treating physician. Chemotherapy must be held during study therapy and can resume 7-14 days after completion of all study therapy (SBRT) at the discretion of treating physician. (Patients may continue anti-endocrine/hormone therapy before, during and after study therapy at the discretion of the treating medical oncologist.)
Clinically significant uncontrolled illness such that the patient is no longer a candidate for systemic therapy
Prior or concurrent malignancy. Prior malignancies with a low probability of recurrence requiring treatment such as the following are allowed: carcinoma in situ of the cervix, non-melanoma skin cancer, and low grade (Gleason score ≤ 6 = Gleason group 1) localized prostate cancer. Prior malignancies not listed require principal investigator (PI) approval
Patients that have only liver metastases will not be allowed
Females only: Pregnant or breastfeeding
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Proportion of patients that remain on their original systemic therapy for at least ≥ 24 weeks post stereotactic body radiation therapy (SBRT) treatmentUp to 24 weeks post SBRT treatment
Analysis will be descriptive in nature and will include the counts and percentages of patients who are responders versus (vs.) non-responders. Results will summarize groups based on intent-to treat.