Study for Using Radiosurgery on Limited Metastases of Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. The standard therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second purpose of this study is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to the quality of life while on this treatment.

Detailed Description
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Before treatment begins, you will have a physical exam and blood tests. Physical evaluations and blood tests will be done each week while you are receiving treatment, and at follow-up visits. You will be seen for follow-up evaluations 4 weeks after treatment is completed, and every three months thereafter. You will be asked to fill out a Quality of Life questionnaire, which should take 5-10 minutes to complete. This will be done prior to treatment and at your follow-up visits. You will receive high dose radiation therapy directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated.

Official Title
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A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer

Conditions
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Breast Cancer, Metastatic

Intervention / Treatment
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* Procedure: Hypofractionated Stereotactic Body Radiation Therapy
* Radiation: Hypofractionated Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: no limit Karnofsky performance status (KPS) ≥ 70 No more than 5 metastatic sites involving one or more different organs (liver, lung or bone). The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol. Previously treated lesions are not eligible unless the prescribed dose can be safely delivered. Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist. Informed consent must be obtained. Pregnancy test must be negative for women of child bearing potential Exclusion Criteria: Inability of patient to be followed longitudinally as specified by protocol. Technical inability to achieve required dose based on safe dose constraints required for radiosurgery. Women who are pregnant or nursing. Failure to meet requirements in Inclusion Criteria Contraindications to radiation.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated Stereotactic Body Radiation Therapy<br>Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. | Procedure: Hypofractionated Stereotactic Body Radiation Therapy<br>* Hypofractionated Stereotactic Body Radiation Therapy<br>Radiation: Hypofractionated Stereotactic Body Radiation Therapy<br>* Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The percent of patients that survived from date of enrollment until 2 year follow-up visit. | 2 years | 
| Overall Survival | The percent of patients that survived from date of enrollment until 4 year follow-up visit | 4 years | 
| Overall Survival | The percent of patients that survived from date of enrollment until 6 year follow-up visit | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients With Lesion Local Control | Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure. | 6 years | 
| Number of Participants Who Experienced a Grade 4 or 5 Toxicity | Number of participants who experienced a grade 4 or 5 toxicity | 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conformal radiotherapy