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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


Phase 2
18 Years
85 Years
Not Enrolling
Both
Breast Cancer Metastatic to the Liver

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

ALison R Calkins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Joseph's Hospital, Department of Radiation Therapy

Authority:

United States: Food and Drug Administration

Study ID:

SJCI023

NCT ID:

NCT00891800

Start Date:

July 2007

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer Metastatic to the Liver
  • Cancer
  • Breast
  • Liver
  • Breast Neoplasms
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location
St. Joseph's Hospital, Department of Radiation Therapy Tampa, Florida  33607