Breast Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONStereotactic Body Radiation Therapy (SBRT)
fractionated linear accelerator based SBRT to 40 Gy in 5 fractions
Sponsors
Stony Brook University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of acute and late adverse events grade 3 or greater | 5 years | Rates of acute and late grade 3 or greater toxicity |
| Partial and complete response rate by clinical and radiographic response | 5 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 5 years | Progression-free survival and overall survival |
Countries
United States
Outcome results
None listed