Study on Cemiplimab and Y-90 SIR-S Spheres for Treating Liver Metastases in Breast Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT06860815

This clinical trial is exploring a new treatment combining cemiplimab, an immunotherapy drug, with a special type of radiation therapy called transarterial radioembolization (TARE) using Y-90 SIR-Spheres. The study aims to see if this combination can effectively target and treat breast cancer that has spread to the liver.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to test how well a combination of cemiplimab, an immunotherapy drug, and a targeted radiation treatment called transarterial radioembolization (TARE) with Y-90 SIR-Spheres works in treating breast cancer that has spread to the liver. Cemiplimab helps the immune system attack cancer cells, while TARE delivers radiation directly to the liver tumors to block their blood supply and slow their growth. This approach may help kill more cancer cells in patients with metastatic breast cancer.

Description

The main goal of this study is to see how cemiplimab and Y-90 SIR-Spheres affect the immune system's response to liver tumors in patients with metastatic breast cancer. Researchers will also look at how the treatment changes the tumor environment and how it affects the immune system throughout the body. The safety and side effects of the treatment will be closely monitored.

Patients will receive cemiplimab through an IV every 21 days for up to a year, as long as the cancer does not progress or cause unacceptable side effects. The Y-90 SIR-Spheres will be delivered directly to the liver tumors through a procedure called TARE, which will be done twice during the study. Patients will also have tumor biopsies and regular blood tests and scans to monitor their response to the treatment.

After completing the treatment, patients will have follow-up visits 30 days later, every 3 months for the first year, and then every 6 months for up to 2 years to check on their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

Must provide informed consent to participate.
Must agree to use previous tumor biopsy samples if available.
Must be 18 years or older.
Must have a good performance status (ECOG 0-1).
Must have a life expectancy of at least 12 weeks.
Female patients must be post-menopausal or have a negative pregnancy test.
Male patients must use contraception if they have a pre-menopausal female partner.
Must have metastatic breast cancer previously treated with at least one line of chemotherapy.
Must be a candidate for TARE with measurable liver tumors.
Liver tumor burden must be less than 50%.
No signs of liver cirrhosis.
Other stable treated metastases are allowed.
Must have recovered from previous cancer treatment side effects.
Must weigh more than 30 kg.
No active hepatitis.
Must meet specific blood count and liver function criteria.

Exclusion Criteria

Received immunotherapy in the past 12 months.
Have untreated or progressing cancer outside the liver.
Have autoimmune diseases requiring treatment.
Have portal vein invasion or extensive liver disease.
Had major surgery within 28 days before the study.
Participating in another clinical study with an investigational product.
Have unresolved side effects from previous cancer treatments.
Have active or prior autoimmune or inflammatory disorders.
Have a history of organ transplantation.
Have uncontrolled illnesses or infections.
Have a history of other primary cancers unless treated and inactive for 5 years.
Have active infections like HIV, hepatitis B, or C.
Have received a live vaccine recently.
Are pregnant or breastfeeding, or not using effective contraception if of childbearing potential.
Have cardiovascular disease or require ongoing steroid treatment.

Locations

FACILITY	ZIP	CITY	STATE
City of Hope Medical Center	91010	Duarte	California

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