SBRT for Breast Cancer
(SBRT BREAST Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAlexander M. Stessin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Stony Brook University

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a focused radiation treatment for breast cancer patients who don't have surgery. It aims to see if this treatment is safe and effective by giving high doses of radiation in a few sessions. The study will follow patients over several years to monitor results. The treatment is being explored for its effectiveness in delaying the switch to other treatments in breast cancer patients.

Eligibility Criteria

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.

Inclusion Criteria

Patient is to be treated at Stony Brook University Hospital

I am not post-menopausal, have a negative pregnancy test, and agree to use contraception during the study.

My breast cancer is in stages T1 to T4.

+5 more

Exclusion Criteria

Inability to understand or unwillingness to sign a written consent document

I am not pregnant, breastfeeding, and if able to become pregnant, I am using or willing to use birth control during the study.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

+5 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: ActiveExperimental Treatment1 Intervention

Stereotactic Body Radiation Therapy (SBRT) is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Stereotactic Body Radiation Therapy for: