Breast CancerSBRT BREASTNCT04532177
Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Breast Cancer, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
Official title: Prospective Pilot Study of Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
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.
- Conditions
- Breast Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
fractionated linear accelerator based SBRT to 40 Gy in 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of acute and late adverse events grade 3 or greater
Rates of acute and late grade 3 or greater toxicity
Measured: 5 years
Partial and complete response rate by clinical and radiographic response
Measured: 5 years
Secondary outcomes (1)
Survival
Progression-free survival and overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start19 Aug 2020
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Stessin, Stony Brook University
- Investigators
- Alexander M Stessin, MD, Principal investigator, Stony Brook Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532177
- Sponsor's protocol ID
- SBU-SBRT-BREAST-NO-SX
- Acronym
- SBRT BREAST
- Status last verified
- Dec 2025
- First submitted
- 25 Aug 2020
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
- ClinicalTrials.gov ID
- NCT04532177
- Acronym / sponsor ID
- SBRT BREAST / SBU-SBRT-BREAST-NO-SX
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)fractionated linear accelerator based SBRT to 40 Gy in 5 fractions | Radiation | Active |
Primary outcome
Rates of acute and late adverse events grade 3 or greater
Time frame: 5 years
Rates of acute and late grade 3 or greater toxicity
Partial and complete response rate by clinical and radiographic response
Time frame: 5 years
1 secondary outcome
Survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander M Stessin, MD principal investigator
Stony Brook Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Breast Cancer, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of acute and late adverse events grade 3 or greater (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.