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NCT06860815 · ClinicalTrials.gov registry record · Phase 2
Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed 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
- 11
- Enrollment target
- 1
- Study location
NCT06860815: Recruiting Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, sponsored by City of Hope Medical Center.
NCT06860815 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 11 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06860815, 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
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests how well cemiplimab and transarterial radioembolization (TARE) with yttrium-90 (Y90) SIR-Spheres, registered trademark, works in treating breast cancer that has spread from where it first started (primary site) to the liver (metastatic). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. TARE is a treatment that uses radioactive microspheres, such as Y90 SIR-S Spheres, to both cause hepatic artery embolization and to deliver regional radiotherapy. Y90 SIR-S Spheres is an injectable form of the radioisotope yttrium Y 90 encapsulated in resin microspheres. When injected into the artery supplying the tumor, yttrium Y 90 resin microspheres block the tumor blood vessels and deliver the yttrium Y 90 directly to the tumor site, which may kill or slow tumor growth. Giving cemiplimab and Y90 SIR-Spheres by TARE to the tumor in the liver may kill more tumor cells in patients with metastatic breast cancer.
Primary Outcome
Will be analyzed using multiplex immunofluorescence (IF) of formalin-fixed paraffin-embedded (FFPE) tissue. Will estimated the mean and standard deviation of the percent change.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Cemiplimab
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 2 |
What NCT06860815 shows while recruiting
NCT06860815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 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 (93% 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.
NCT06860815 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06860815 about?
NCT06860815 is a clinical study titled "Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer". This phase II trial tests how well cemiplimab and transarterial radioembolization (TARE) with yttrium-90 (Y90) SIR-Spheres, registered trademark, works in treating breast cancer that has spread from where it first started (primary site) to the liver (metastatic). Immunotherapy with monoclonal antibo...
What is the current status of trial NCT06860815?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2026-04-01. Estimated completion is 2027-01-30.
What conditions does trial NCT06860815 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Carcinoma in the Liver.
What interventions are being tested in trial NCT06860815?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cemiplimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06860815?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06860815 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06860815's enrollment target sits among peer trials
11 56th of 59 higher than 4 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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