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NCT06260033 · ClinicalTrials.gov registry record · Phase 2
Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer
A Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 2
- Study locations
NCT06260033: Recruiting Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, sponsored by City of Hope Medical Center.
NCT06260033 is a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 18 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06260033, a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- PROCEDURE Bone Scan
- DRUG F-18 16 Alpha-Fluoroestradiol
Study Locations (2)
California
- City of Hope Medical Center - Duarte
- City of Hope at Irvine Lennar - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-07-23 |
| Est. Completion | 2026-10-29 |
| Phase | Phase 2 |
What NCT06260033 shows while recruiting
NCT06260033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06260033 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06260033 about?
NCT06260033 is a clinical study titled "Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer". 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). C...
What is the current status of trial NCT06260033?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2024-07-23. Estimated completion is 2026-10-29.
What conditions does trial NCT06260033 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Estrogen Receptor-Positive Breast Carcinoma.
What interventions are being tested in trial NCT06260033?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Bone Scan (PROCEDURE), F-18 16 Alpha-Fluoroestradiol (DRUG).
Who is sponsoring clinical trial NCT06260033?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06260033 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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