15 Participants Needed

SBRT for Breast Cancer

(SBRT BREAST Trial)

JR
PT
Overseen ByPushpa Talanki
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Stony Brook University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the SBRT breast cancer trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) for breast cancer?

Research shows that Stereotactic Body Radiation Therapy (SBRT) is effective in treating early-stage lung cancer by precisely targeting tumors with high doses of radiation, which suggests it may also be beneficial for other cancers like breast cancer.12345

Is SBRT generally safe for humans?

SBRT has been used safely in patients with lung cancer and other conditions, showing an excellent safety profile with some known side effects like lung and chest wall issues. However, specific adverse effects like vertebral fractures have been noted in certain cases.678910

How is the treatment SBRT for breast cancer different from other treatments?

SBRT (Stereotactic Body Radiation Therapy) for breast cancer is unique because it delivers highly precise radiation doses to the tumor, potentially allowing patients who might not qualify for breast-conserving surgery to receive effective treatment. It is minimally invasive and can be combined with chemotherapy before surgery to determine the maximum safe dose, offering a novel approach compared to traditional radiation therapies.1011121314

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.

Research Team

Dr. Alexander M. Stessin, MD, PhD ...

Alexander M. Stessin

Principal Investigator

Stony Brook Cancer Center

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.
See 4 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.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic body radiation therapy (SBRT) to a dose of 40 Gy over the course of 5 fractions

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

  • Stereotactic Body Radiation Therapy (SBRT)
Trial Overview 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.
Participant Groups
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:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors
🇪🇺
Approved in European Union as Stereotactic Body Radiation Therapy for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors
🇨🇦
Approved in Canada as Stereotactic Body Radiation Therapy for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors
🇯🇵
Approved in Japan as Stereotactic Body Radiation Therapy for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials
225
Recruited
41,700+

Findings from Research

In a study of 92 patients with early-stage non-small cell lung cancer (NSCLC) tumors measuring ≥5 cm, stereotactic body radiotherapy (SBRT) demonstrated high local control rates of 95.7% at 1 year and 73.2% at 2 years, indicating its efficacy for larger tumors.
The treatment was found to be safe, with only 1% of patients experiencing grade 3 dermatitis and 4% experiencing grade 3 radiation pneumonitis, suggesting that serious side effects are relatively rare.
Multi-institutional experience of stereotactic body radiotherapy for large (≥5 centimeters) non-small cell lung tumors.Verma, V., Shostrom, VK., Kumar, SS., et al.[2018]
Stereotactic body radiotherapy (SBRT) is an effective treatment for patients with stage I non-small cell lung cancer (NSCLC) who cannot undergo surgery, with a median overall survival of 30 months for T1 tumors and 26 months for T2 tumors based on a study of 723 patients.
Higher biological equivalent doses (BED10) of SBRT significantly improve local control rates for T2 tumors, with a local failure rate dropping from 32% to 8% as the BED10 increases from <105 Gy to ≥150 Gy.
Stereotactic body radiotherapy for early-stage non-small cell lung cancer: clinical outcomes from a National Patient Registry.Davis, JN., Medbery, C., Sharma, S., et al.[2022]
Lung stereotactic body radiation therapy (SBRT) is an effective treatment option for early-stage non-small cell lung cancer (NSCLC) and is increasingly being used for more advanced cases.
The review highlights current treatment recommendations and planning for SBRT, indicating its growing role in managing lung cancer.
Lung Stereotactic Body Radiation Therapy.Rehman, S., Roach, MC., Bradley, JD., et al.[2018]

References

SU-E-T-456: Potential Optimization of Stereotactic Body Radation Therapy (SBRT) from a Simple Field Timing Rearrangement. [2019]
Multi-institutional experience of stereotactic body radiotherapy for large (≥5 centimeters) non-small cell lung tumors. [2018]
Stereotactic body radiotherapy for early-stage non-small cell lung cancer: clinical outcomes from a National Patient Registry. [2022]
Lung Stereotactic Body Radiation Therapy. [2018]
Local control and survival after stereotactic body radiation therapy of early-stage lung cancer patients in Slovenia. [2023]
Stereotactic body radiation therapy for patients with lung cancer previously treated with thoracic radiation. [2022]
Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. [2022]
Stereotactic body radiotherapy (SBRT) for multiple pulmonary oligometastases: Analysis of number and timing of repeat SBRT as impact factors on treatment safety and efficacy. [2018]
Five-year follow-up after stereotactic body radiotherapy for medically inoperable early-stage non-small cell lung cancer: a multicenter study. [2023]
Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. [2022]
Multi-center evaluation of dose conformity in stereotactic body radiotherapy. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Phase 1 clinical trial of stereotactic body radiation therapy concomitant with neoadjuvant chemotherapy for breast cancer. [2022]
Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]
The role of SBRT in oligometastatic patients with liver metastases from breast cancer. [2020]
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