Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery (SBRT BREAST)
Primary Purpose
Breast Cancer
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
Sponsored by

About this trial
This is an interventional treatment trial for Breast Cancer
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
Sites / Locations
- Stony Brook University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
Outcomes
Primary Outcome Measures
Rates of acute and late adverse events grade 3 or greater
Rates of acute and late grade 3 or greater toxicity
Partial and complete response rate by clinical and radiographic response
Secondary Outcome Measures
Survival
Progression-free survival and overall survival
Full Information
NCT ID
NCT04532177
First Posted
August 25, 2020
Last Updated
October 16, 2023
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT04532177
Brief Title
Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Acronym
SBRT BREAST
Official Title
Prospective Pilot Study of Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Intervention Description
fractionated linear accelerator based SBRT to 40 Gy in 5 fractions
Primary Outcome Measure Information:
Title
Rates of acute and late adverse events grade 3 or greater
Description
Rates of acute and late grade 3 or greater toxicity
Time Frame
5 years
Title
Partial and complete response rate by clinical and radiographic response
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Survival
Description
Progression-free survival and overall survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander M Stessin, MD
Organizational Affiliation
Stony Brook Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
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