A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
City of Hope Medical Center
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.
Description
PRIMARY OBJECTIVE: I. To determine whether using SBRT to treat oligoprogressive lesions allows ER+ breast cancer patients to continue on their current systemic therapy for at least 24 weeks post SBRT treatment. SECONDARY OBJECTIVES: I. To evaluate adverse events (Common Terminology Criteria in Adverse Events \[CTCAE\] and Patient-Reported Outcomes PRO-CTCAE) in patients who receive SBRT. II. To assess whether F-18 16 alpha-fluoroestradiol (FES)-PET increases the number of lesions found prior to SBRT. III. To determine the impact of SBRT on patient quality of life using the European Organi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
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
Locations (2)
- City of Hope Medical CenterDuarte, California
- City of Hope at Irvine LennarIrvine, California