What side effects are associated with this type of intervention?

Stereotactic Body Radiation Therapy (SBRT) for breast cancer is designed to minimize damage to surrounding healthy tissue by delivering high doses of radiation precisely to the tumor site. Common side effects of SBRT include skin irritation, fatigue, and localized pain. More broadly, breast cancer treatments can lead to side effects such as cardiotoxicity, infertility, cataracts, secondary cancers, neurocognitive dysfunction, endocrinopathies, depression, fatigue, and anxiety. The specific side effects experienced can vary based on the type and intensity of the therapy used.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that involve precise targeting of tumors, similar to Stereotactic Body Radiation Therapy (SBRT). These include various forms of radiation therapy such as External Beam Radiation Therapy (EBRT) and Intensity-Modulated Radiation Therapy (IMRT), which deliver high doses of radiation to the tumor while minimizing damage to surrounding healthy tissue. Additionally, systemic treatments like trastuzumab (Herceptin) and pertuzumab (Perjeta) for HER2-positive breast cancer have been approved, often used in combination with radiation therapy to enhance treatment efficacy.

What other types of research exist?

Promising novel alternatives to SBRT for breast cancer patients include: 1) Proton Beam Therapy (PBT), which uses protons instead of X-rays to deliver precise radiation doses with minimal damage to surrounding tissues. 2) Intraoperative Radiation Therapy (IORT), which delivers a concentrated dose of radiation during surgery directly to the tumor bed, reducing exposure to healthy tissue. 3) Radioenhancers, such as nanoparticles (e.g., NBTXR3), which enhance the effects of radiation therapy, allowing for lower doses and reduced side effects.

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Radiation Therapy

SBRT for Breast Cancer (SBRT BREAST Trial)

Q: What is the mechanism of action of this treatment?

Stereotactic Body Radiation Therapy (SBRT) delivers high doses of radiation precisely to the tumor site, minimizing damage to surrounding healthy tissue, which is crucial for reducing side effects and preserving the function of nearby organs. Other common treatments include surgery to remove the tumor, chemotherapy to kill rapidly dividing cancer cells, hormone therapy to block hormones that fuel certain types of breast cancer, and targeted therapy to attack specific molecules involved in cancer growth. Understanding these mechanisms helps in selecting the most appropriate treatment based on the cancer's characteristics and the patient's overall health.

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

Must not have

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

Children (< 18 years of age)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

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.

Select...

My breast cancer is in stages T1 to T4.

Select...

My breast cancer was confirmed by a biopsy.

Select...

I am 18 years old or older.

Select...

My cancer cannot be removed by surgery, or I am not fit for surgery as determined by a surgeon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am under 18 years old.

Select...

My body shape or size prevents me from receiving the study treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rates of acute and late adverse events grade 3 or greater

Secondary study objectives

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

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

Study treatment Arm

Gem + Xeloda + SBRT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~950

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Stereotactic Body Radiation Therapy (SBRT) delivers high doses of radiation precisely to the tumor site, minimizing damage to surrounding healthy tissue, which is crucial for reducing side effects and preserving the function of nearby organs. Other common treatments include surgery to remove the tumor, chemotherapy to kill rapidly dividing cancer cells, hormone therapy to block hormones that fuel certain types of breast cancer, and targeted therapy to attack specific molecules involved in cancer growth. Understanding these mechanisms helps in selecting the most appropriate treatment based on the cancer's characteristics and the patient's overall health.