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Radiation Therapy

SBRT for Breast Cancer (SBRT BREAST Trial)

Phase < 1
Waitlist Available
Led By Alexander M Stessin, MD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Clinical T1-T4 invasive carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

SBRT BREAST Trial Summary

This trial is testing whether SBRT is a safe and effective treatment for breast cancer patients who don't get surgery. 15 patients will be treated with 5 doses of radiation over 5 weeks, and followed for 5 years.

Who is the study for?
This trial is for adults with invasive breast cancer that can't be removed by surgery or who aren't good candidates for surgery. Participants must have a life expectancy over 6 months, understand and sign consent, and women of childbearing age must use contraception. It's not for those with breast implants in the affected area, life expectancy under 6 months, inadequate imaging, body habitus issues preventing treatment planning, pregnant or breastfeeding women, or those unable to follow study requirements.Check my eligibility
What is being tested?
The trial tests Stereotactic Body Radiation Therapy (SBRT) as an alternative to surgery for treating breast cancer. Fifteen patients will receive a total radiation dose of 40 Gy in five sessions at Stony Brook University Hospital and will be monitored over five years to assess safety and effectiveness.See study design
What are the potential side effects?
While specific side effects are not listed here, SBRT may generally cause skin reactions at the treatment site, fatigue, pain or discomfort in the treated area. Rarely it might lead to more serious complications like damage to nearby organs.

SBRT BREAST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not post-menopausal, have a negative pregnancy test, and agree to use contraception during the study.
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My breast cancer is in stages T1 to T4.
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My breast cancer was confirmed by a biopsy.
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I am 18 years old or older.
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My cancer cannot be removed by surgery, or I am not fit for surgery as determined by a surgeon.

SBRT BREAST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Partial and complete response rate by clinical and radiographic response
Rates of acute and late adverse events grade 3 or greater
Secondary outcome measures
Survival

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593
21%
Anemia
18%
Neutropenia
15%
Hypoalbuminemia
15%
White blood cell decreased ( leukopenia)
15%
Diarrhea
12%
Liver Dysfunction
9%
Hand-Foot
3%
Bleeding
3%
Stroke
3%
Abdominal Infection
3%
Ileus
3%
Mucositis
3%
Edema
3%
Dermatitis
3%
Platelet count decreased ( Thrombocytopenia)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gem + Xeloda + SBRT

SBRT BREAST Trial Design

1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
213 Previous Clinical Trials
39,512 Total Patients Enrolled
5 Trials studying Breast Cancer
260 Patients Enrolled for Breast Cancer
Alexander M Stessin, MDPrincipal InvestigatorStony Brook Cancer Center

Media Library

Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04532177 — Phase < 1
Breast Cancer Research Study Groups: Active
Breast Cancer Clinical Trial 2023: Stereotactic Body Radiation Therapy (SBRT) Highlights & Side Effects. Trial Name: NCT04532177 — Phase < 1
Stereotactic Body Radiation Therapy (SBRT) (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04532177 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently an open enrollment period for this research?

"Confirming the clinicaltrials.gov information, this clinical trial is no longer searching for participants. This study was originally launched on August 19th 2020 and has since been updated last September 1st 2022. There are currently 2601 other medical trials that are actively recruiting patients at this time though."

Answered by AI

Who else is applying?

What site did they apply to?
Stony Brook University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Stony Brook University Hospital: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery
Alexander Stessin 2020. "Stereotactic Body Radiation Therapy (SBRT) for Invasive Breast Cancer Patients Not Undergoing Definitive Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04532177.
All > Sbrt
~7 spots leftby Aug 2027
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