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

NCT ID: NCT04532177

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2027-08-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active

Group Type EXPERIMENTAL

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type RADIATION

fractionated linear accelerator based SBRT to 40 Gy in 5 fractions

Interventions

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Stereotactic Body Radiation Therapy (SBRT)

fractionated linear accelerator based SBRT to 40 Gy in 5 fractions

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Alexander Stessin

Clinical Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander M Stessin, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Cancer Center

Locations

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Stony Brook University Hospital

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SBU-SBRT-BREAST-NO-SX

Identifier Type: -

Identifier Source: org_study_id