Breast Cancer Metastatic to the Liver Clinical Trial
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
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
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. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment