Stereotactic Body Radiation Therapy (SBRT) for Invasive B... | NCT04532177

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

NCT04532177

Sponsor

Stony Brook University

Status

Active, not recruiting

Last Update Posted

Dec 17, 2025Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Stereotactic Body Radiation Therapy (SBRT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 19, 2020Actual

Primary Completion Date

Aug 31, 2027Estimated

Completion Date

Aug 31, 2027Estimated

First Submitted Date

Aug 25, 2020

First Submission Date that Met QC Criteria

Aug 25, 2020

First Posted Date

Aug 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2025

Last Update Posted Date

Dec 17, 2025Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Label	Type	Description	Intervention Names
Active	Experimental		Radiation: Stereotactic Body Radiation Therapy (SBRT)

Name	Type	Description	Arm Group Labels	Other Names
Stereotactic Body Radiation Therapy (SBRT)	Radiation	fractionated linear accelerator based SBRT to 40 Gy in 5 fractions	Active

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures