Actively Recruiting
Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer
Led by City of Hope Medical Center · Updated on 2026-01-28
11
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and assent if appropriate
- Agreement to provide archival tissue or approval for exceptions
- Age 18 years or older
- ECOG performance status 0-1
- Life expectancy of at least 12 weeks
- Post-menopausal status or negative pregnancy test for women of childbearing potential
- Male patients must be surgically sterile or use contraception if sexually active with a pre-menopausal partner
- Metastatic breast cancer treated with at least one chemotherapy line in metastatic setting
- Candidate for TARE with measurable liver metastases per RECIST 1.1
- Liver tumor burden less than 50%
- No evidence of cirrhosis
- Other stable treated metastases allowed
- Recovered from acute toxic effects to grade 1 or less (except alopecia) from prior therapy
- Body weight over 30 kg
- No untreated active hepatitis
- Hemoglobin at least 9.0 g/dL
- Absolute neutrophil count at least 1500/uL
- Platelet count at least 75000/uL
- Total bilirubin less than 2.0 mg/dL
- AST and ALT less than or equal to 5 times upper limit of normal
- Albumin at least 2.8 g/dL
- INR less than or equal to 1.6
- Creatinine clearance over 40 mL/min
You will not qualify if you...
- Prior immunotherapy within 12 months
- Progressing or untreated metastases outside the liver
- Autoimmune disease requiring immunosuppressive therapy or immunodeficiency
- Any condition posing safety concerns per investigator
- Portal vein invasion
- Liver tumor burden over 50%
- Major surgery within 28 days prior to radioembolization except local palliative surgery
- Participation in other investigational studies within 4 weeks
- Recent anticancer therapy within 28 days without adequate washout
- Prior anti-PD-1/PD-L1 or anti-CTLA4 inhibitor exposure within 12 months
- Unresolved toxicities grade 2 or higher from prior therapy (except alopecia and specified labs)
- Grade 2 or higher neuropathy without physician approval
- Active or prior autoimmune/inflammatory disorders except specified exceptions
- History of organ transplantation
- Expected lung radiation dose over 30 Gy
- Uncontrolled illnesses or infections including HIV, hepatitis B or C unless controlled
- History of other malignancies except certain treated types
- Receipt of live vaccines within 30 days prior to study
- Pregnant or breastfeeding women
- Patients unwilling to use effective contraception
- Known hypersensitivity to study drugs
- Use of immunosuppressive medications within 14 days prior to treatment except certain exceptions
- Presence of significant cardiovascular disease
- Inability or unwillingness to comply with study procedures
- Receipt of COVID-19 vaccine within 1 week of planned treatment start
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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