Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to study whether or not the use of direct radiation therapy with Y-90 microspheres (SIR-Spheres) has any effect on treated liver with respect to tumor response in breast cancer patients. Criteria: Breast cancer Clinical evidence of metastatic disease in the liver Performance status (0-2) Not pregnant Laboratory values received after any prior chemotherapy Normal Pt/PTT recovered from any chemotherapy side-effects No prior radiation therapy to the liver No other MAJOR site of cancer such as lungs or brain No uncontrolled infections a candidate for surgical resection or ablation therapy

Detailed Description
-----------------
Patient must pass an MAA angiography study to detect abnormal shunting of the vessels to the lungs and stomach. Shunting of the radiation seeds to these areas, if an abnormality exists would be harmful.

Official Title
-----------------
A Phase II Feasibility Study to Assess the Use of SIR-Sphere in Patients With Breast Cancer Who Have Chemotherapy-Resistant Disease in the Liver

Conditions
-----------------
Breast Cancer Metastatic to the Liver

Intervention / Treatment
-----------------
* Device: Brachytherapy
* Device: SIR-Sphere


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented breast cancer Clinical evidence of mets to the liver Performance status of 0-2 Life expectancy of greater equal to 3 months Not pregnant 4 weeks or more since last radiation therapy Recovered from all side effects of prior chemotherapy Not needing concurrent chemotherapy recovered laboratory values Bilirubin < 2.0 Exclusion Criteria: Candidate for surgical resection or ablation of liver lesion/s Prior radiation therapy to the liver Co-Morbid disease pulmonary insufficiency Portal vein thrombosis Contraindications to angiography > 20 % lung shunting on MAA Diffuse extra-hepatic disease Concurrent chemotherapy OR capecitabine with 8 weeks Failed MAA Uncontrolled active infection Severe liver dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All patients will be treated with SIR-Sphere therapy. | Device: Brachytherapy<br>* SIR-Sphere contains radiation of Y-90.<br>* Other names: Radiation seeds;Device: SIR-Sphere<br>* Brachytherapy Radiation seeds<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: Assessment of the feasibility of SIRT treatment as measured by tumor response in the treated labe/s of the liver.Assessed by CT scan and measurement Secondary Response: Assessment of treatment toxicity. Assessed by examination and blood work. |  | Patients will be followed for 5 years or Progressive disease in the treated liver or until such time as systemic therapy is needed for disease in other organs which will affect tumor response in the liver. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Breast, Liver