SBRT for Breast Cancer

(SBRT BREAST Trial)

Overseen By Pushpa Talanki

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stony Brook University

Disqualifiers: Pregnancy, Breastfeeding, Breast implant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment called stereotactic body radiation therapy (SBRT) for breast cancer patients who cannot undergo surgery. The goal is to determine if SBRT is safe and effective for these patients. It targets those diagnosed with breast cancer that cannot be surgically removed. Participants must receive treatment at Stony Brook University Hospital and require a doctor's confirmation that surgery is not an option. As an Early Phase 1 trial, participants will be among the first to receive this innovative treatment, contributing to understanding its safety and effectiveness.

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 prior data suggests that stereotactic body radiation therapy (SBRT) is safe for breast cancer patients?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) is generally safe for patients. In one study with 35 patients, standard doses of SBRT resulted in no serious side effects. Importantly, no dose-limiting toxicities occurred, indicating patients tolerated the treatment well. Another review found that early side effects of SBRT for breast cancer were mild, with most patients not experiencing severe problems.

Although data on SBRT specifically for breast cancer is limited, the treatment is already used for other cancer types, suggesting it is generally well-tolerated. Some studies have used SBRT in breast cancer cases and found it delayed the need for more aggressive treatments, indicating potential safety. However, SBRT for breast cancer remains under investigation, and more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Stereotactic Body Radiation Therapy (SBRT) is unique because it delivers high doses of radiation precisely to the tumor in fewer sessions compared to traditional radiation therapy. Unlike standard treatments that may require several weeks of daily sessions, SBRT can complete therapy in just a few days, which is more convenient for patients. Researchers are excited about SBRT because its precision minimizes damage to surrounding healthy tissue, potentially leading to fewer side effects and improved quality of life for patients with breast cancer.

What evidence suggests that stereotactic body radiation therapy (SBRT) might be an effective treatment for breast cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT), which participants in this trial will receive, holds promise for treating various cancers, including breast cancer. Studies have found that SBRT can delay the need for additional treatments in breast cancer patients by over a year. The time patients live without disease progression ranges from 17% to 57%, and survival rates after treatment range from 62% to 91%. Early findings also suggest that SBRT helps maintain the breast's appearance. Although SBRT is widely used in some breast cancer cases, further research is needed to fully understand its effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Alexander M. Stessin

Principal Investigator

Stony Brook Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Published Research Related to This Trial

In a study of 145 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic body radiotherapy (SBRT), the treatment demonstrated a high local control rate with only 24.1% experiencing disease recurrence over a median follow-up of 65.6 months.

SBRT was associated with low toxicity, as only 3.4% of patients experienced grade 3 adverse events, and no patients suffered from severe (grade 4 or 5) toxicities, indicating that it is a safe treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year follow-up after stereotactic body radiotherapy for medically inoperable early-stage non-small cell lung cancer: a multicenter study. Guo, Y., Zhu, Y., Zhang, R., et al.[2023]

Stereotactic body radiation therapy (SBRT) is a preferred treatment for early-stage non-small cell lung cancer (NSCLC) patients who cannot undergo surgery, but accurate lymph node staging is crucial for optimal patient selection.

Current staging methods like PET/CT and EBUS have limited sensitivity in detecting lymph node metastases, which can lead to undetected cancer spread and poorer outcomes; thus, invasive staging procedures are often necessary to improve detection and potentially enhance survival with adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Stereotactic Body Radiation Therapy. Rehman, S., Roach, MC., Bradley, JD., et al.[2018]

Stereotactic body radiation therapy (SBRT) for early-stage lung cancer showed a high local control rate of 98% at 1 year and 95% at 5 years, indicating its effectiveness in managing tumors non-invasively.

The treatment was well tolerated, with only one severe toxicity (Grade 4 pneumonitis) reported among 28 recorded toxicities, suggesting a favorable safety profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local control and survival after stereotactic body radiation therapy of early-stage lung cancer patients in Slovenia. Stanic, K., But-Hadzic, J., Zagar, J., et al.[2023]

Stereotactic body radiation therapy (SBRT) demonstrated a 3-year overall survival rate of 59.9% for inoperable patients and 76.5% for operable patients with T1N0M0 non-small cell lung cancer, indicating its efficacy as a treatment option.

The treatment was associated with low rates of severe toxicities, with only 10 patients experiencing grade 3 and 2 patients experiencing grade 4 toxicities, suggesting that SBRT is a safe alternative to surgery for early-stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. Nagata, Y., Hiraoka, M., Shibata, T., et al.[2022]

A 68-year-old woman treated with stereotactic body radiation therapy (SBRT) for lung metastases experienced pathological vertebral fractures ten months post-treatment, highlighting a previously unreported adverse effect of SBRT.

Despite achieving a complete response of the metastatic disease without signs of radiation pneumonitis, the case emphasizes the need for oncologists to consider the risk of bone toxicity, particularly in older patients with potential low bone mineral density (BMD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. Rodríguez-Ruiz, ME., San Miguel, I., Gil-Bazo, I., et al.[2022]

In a study of 145 patients with multiple pulmonary metastases treated with stereotactic body radiotherapy (SBRT), the overall survival (OS) was 23.5 months, indicating that SBRT is effective for this condition.

The study found no increase in the risk of early death or severe toxicity (grade 4 or 5) associated with multiple SBRT treatments, suggesting a strong safety profile for this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy (SBRT) for multiple pulmonary oligometastases: Analysis of number and timing of repeat SBRT as impact factors on treatment safety and efficacy. Klement, RJ., Hoerner-Rieber, J., Adebahr, S., et al.[2018]

In a review of stereotactic body radiotherapy (SBRT) plans from 17 centers, it was found that 29% of patient plans compromised target volume coverage to meet organ-at-risk tolerances, highlighting the need for better plan quality metrics that do not rely solely on target coverage.

The study established that the prescription dose spillage (PDS) and modified gradient index (MGI) metrics provide updated guidance for evaluating SBRT plan quality, with PDS values aligning well with existing clinical trial constraints, while MGI values indicated discrepancies that need addressing for optimal treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-center evaluation of dose conformity in stereotactic body radiotherapy. Lee, J., Dean, C., Patel, R., et al.[2022]

Citations

1. redjournal.org redjournal.org/article/S0360-3016(24)01253-7/fulltext

Efficacy of Stereotactic Body Radiation Therapy (SBRT) to ... Follow-up data for disease outcomes was available in 46 of 51 patients with a median follow-up time of 15.5 mos (IQR, 9.4-24.4 mos) post-SBRT.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10378468/

The Effectiveness and Safety of Stereotactic Body ... Progression-free and overall survival ranged from 17 to 57% and 62 to 91%, respectively. There are limited data on the role of SBRT in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625005636

Impact of stereotactic body radiation therapy on systemic ... SBRT is widely used in oligometastatic breast cancer despite limited evidence. •. SBRT delayed systemic therapeutic line change by over 1 year in our cohort. •.

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-024-02497-4

Advances in breast cancer treatment: a systematic review of ... Preoperative SBRT significantly reduce overall treatment time, enabling to minimalize volumes. Early results indicate excellent cosmetic effects and low ...

5. ascopubs.org ascopubs.org/doi/10.1200/GO-25-00004

Metastasis-Directed Stereotactic Body Radiation Therapy ... Conclusion. SBRT is effective and safe for treating OM and OP solid cancers, prolonging FISST and potentially delaying systemic treatments, ...

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2778658

Evaluation of Safety of Stereotactic Body Radiotherapy for ... Standard doses were safe in all 35 evaluable patients, with a median of 3 metastases; there were no protocol-defined dose-limiting toxicities, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11295558/

Advances in breast cancer treatment: a systematic review of ... The early toxicity profile of preoperative SBRT in breast cancer seems to be favorable. Among studies selected for the review, in terms of G3 ...

8. aacrjournals.org aacrjournals.org/cancerres/article/83/5_Supplement/P1-10-05/716949/Abstract-P1-10-05-Safety-of-stereotactic-body

Abstract P1-10-05: Safety of stereotactic body radiation ... The objective of our study is to assess toxicity among patients who received SBRT, stereotactic radiosurgery (SRS), or other high dose RT along ...