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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
Phase 2 trial testing Biospecimen Collection in Anatomic Stage IV Breast Cancer AJCC v8 in 18 participants. Currently enrolling.
29 October 2026
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 23 July 2024 |
| Primary completion | 29 October 2026 |
| Estimated completion | 29 October 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Biospecimen Collection — full drug profile →
- Bone Scan — full drug profile →
- Computed Tomography
- F-18 16 Alpha-Fluoroestradiol — full drug profile →
- Positron Emission Tomography
- Questionnaire Administration
- Stereotactic Body Radiation Therapy — full drug profile →
Conditions studied
- Anatomic Stage IV Breast Cancer AJCC v8 — all drugs for Anatomic Stage IV Breast Cancer AJCC v8 →
- Estrogen Receptor-Positive Breast Carcinoma — all drugs for Estrogen Receptor-Positive Breast Carcinoma →
- Metastatic Breast Carcinoma — all drugs for Metastatic Breast Carcinoma →
Sponsor
City of Hope Medical Center
Who can join
18 and older, any sex, with Anatomic Stage IV Breast Cancer AJCC v8 or Estrogen Receptor-Positive Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Local treatment for oligoprogressive metastatic sites of breast cancer: efficacy, toxicities and future perspectives.
Merloni F, Palleschi M, Gianni C, Sirico M, et al · · 2024 · cited 3× · PMID 39312051 · DOI 10.1007/s10585-024-10312-3 -
Efficacy of Metastasis-Directed Radiation Therapy to Prolong Systemic Therapy for Patients with Oligoprogressive Metastatic Breast Cancer.
LeVee A, Young H, Yoon S, Glaser S, et al · · 2025 · PMID 40647452 · DOI 10.3390/cancers17132153 -
Current Approaches of Nuclear Molecular Imaging in Breast Cancer.
Schäfer L, Altunay B, Heesch A, van Nijnatten T, et al · · 2025 · PMID 40647404 · DOI 10.3390/cancers17132105
Verify or expand the search:
- PubMed search for NCT06260033
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Anatomic Stage IV Breast Cancer AJCC v8
Currently open trials in the same condition.
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Other City of Hope Medical Center trials
Trials by the same sponsor.
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- NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
- NCT07363408 — Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment · Phase 1 · not yet recruiting
- NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
- NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06260033 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
- Last refreshed: 6 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06260033.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing