Clinical trial NCT04532177: Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Official title: Prospective Pilot Study of Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rates of acute and late adverse events grade 3 or greater
timeFrame: 5 years
measure: Partial and complete response rate by clinical and radiographic response
timeFrame: 5 years
Secondary outcomes:
measure: Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook Cancer Center
name: Alexander M Stessin, MD
role: PRINCIPAL_INVESTIGATOR
References: