Clinical trial · Interventional
Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of study patients
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Metastatic to the Liver | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Device | — | UNRESOLVED |
| SIR-Sphere | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- All patients will be treated with SIR-Sphere therapy.
- interventionNames
- Device: Brachytherapy
- Device: SIR-Sphere
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available