Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

Study Overview
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Brief Summary
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This is a prospective pilot study investigating the safety and efficacy of stereotactic body radiation therapy (SBRT) as a treatment for breast cancer in patients who do not get surgery. The study will accrue 15 patients who will be treated to a dose of 40 Gy over the course of 5 fractions in the Stony Brook University Hospital Department of Radiation Oncology. The subjects will then have a follow up time of 5 years.

Official Title
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Prospective Pilot Study of Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 18 Biopsy proven invasive carcinoma of the breast Clinical T1-T4 invasive carcinoma Cancer is deemed unresectable with no possibility of future resection or the patient is a poor surgical candidate as determined following evaluation by a surgeon. Women who are not post-menopausal should have a negative urine or serum pregnancy test. Women of childbearing potential must agree to adequate contraception for the duration of study participation. Ability to understand and willingness to sign a written informed consent document Life expectancy > 6 months Patient is to be treated at Stony Brook University Hospital Exclusion Criteria: Women with a known pregnancy, positive serum pregnancy test, or currently breastfeeding as well as women of childbearing potential unwilling or unable to use an acceptable method of birth control (including abstinence or barrier method of birth control) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Breast implant in the breast to be treated with SBRT Insufficient breast imaging to judge clinical stage Inability to receive study treatment planning and treatment secondary to body habitus Inability to understand or unwillingness to sign a written consent document Life expectancy < 6 months Children (< 18 years of age) Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Active<br> | Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* fractionated linear accelerator based SBRT to 40 Gy in 5 fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of acute and late adverse events grade 3 or greater | Rates of acute and late grade 3 or greater toxicity | 5 years | 
| Partial and complete response rate by clinical and radiographic response |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Progression-free survival and overall survival | 5 years |