45 Participants Needed

Stereotactic Body Radiation Therapy for Breast Cancer

(BOSS Trial)

Recruiting at 2 trial locations
CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether targeted radiation, known as Stereotactic Body Radiation Therapy (SBRT), can delay the need to switch medications for individuals with metastatic breast cancer. Researchers are also investigating if tracking tumor cells in the blood can guide future treatment options. Ideal participants have breast cancer that has spread but are still responding to their current treatment, with only a few areas showing progression outside the brain. As an unphased trial, this study allows participants to contribute to innovative research that could shape future treatment strategies.

Do I need to stop my current medications for this trial?

The trial does not specify that you need to stop your current medications. In fact, it mentions that patients should plan to continue their current systemic therapy.

What prior data suggests that this radiation therapy is safe for metastatic breast cancer patients?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) is generally safe for individuals with breast cancer that has metastasized. Studies have found that SBRT effectively controls tumors and is well-tolerated. For instance, one study found that SBRT effectively prevents tumor growth or spread in the treated area. Another study demonstrated that SBRT remains a safe option for patients with multiple cancer sites, causing only minor side effects.

SBRT targets tumors with high precision, protecting nearby healthy tissue. This accuracy makes it a promising choice for treating specific cancer areas while minimizing side effects.12345

Why are researchers excited about this trial?

Researchers are excited about using Stereotactic Body Radiation Therapy (SBRT) for treating oligoprogressive sites in metastatic breast cancer because it offers precision targeting of tumors with high-dose radiation. Unlike conventional fractionation or palliative treatments that can take longer and impact surrounding healthy tissue, SBRT delivers a concentrated dose in fewer sessions, potentially reducing side effects and improving quality of life. This technique also aims to control disease progression effectively, which might allow patients to continue their existing systemic therapies without needing a switch.

What evidence suggests that Stereotactic body radiation therapy (SBRT) is effective for metastatic breast cancer?

Research has shown that Stereotactic Body Radiation Therapy (SBRT) is a promising treatment for breast cancer that has spread to other parts of the body. In this trial, patients with metastatic breast cancer will receive SBRT, which effectively targets and controls cancerous areas. Studies have found that patients with a few small areas of cancer spread, known as oligometastatic disease, who received SBRT experienced better survival rates compared to those with other types of cancer. Additionally, SBRT is considered safe for patients, making it a good option for managing breast cancer that has spread. These findings suggest that SBRT could help delay the need to change overall cancer treatment in patients whose disease is worsening.12678

Who Is on the Research Team?

RO

Roman O. Kowalchuk, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Inclusion Criteria

You have provided written, informed consent.
You have been diagnosed with primary breast cancer through histological examination.
Patients with metastatic breast cancer who have experienced at least 12 months of positive outcomes from their initial systemic therapy and now present with 1-3 sites of oligoprogressive disease outside the primary tumor.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive metastasis-directed radiation therapy (SBRT) to delay a change in systemic therapy

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Stereotactic Body Radiation Therapy (SBRT)

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Metastatic Breast CancerExperimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Impact of stereotactic body radiation therapy on systemic ...

Many studies of SBRT in patients with OMD highlighted that patient with BC had a potential for higher survival rate compared to other solid ...

Stereotactic Body Radiotherapy for Patients With Breast ...

A number of studies of systemic therapy in metastatic breast cancer have reported that patients with OM disease have a better prognosis compared to other ...

Definitive results of a prospective non-randomized phase 2 ...

SBRT is a safe and valid option in oligometastatic breast cancer patients, with very high rates of local control.

Metastasis-Directed Stereotactic Body Radiation Therapy ...

A total of 257 metastatic lesions were treated, with the cancer of origin distributed as follows: colorectal (74 lesions, 28.8%), breast (43 ...

May 2025

Meta-analysis of randomized controlled trials comparing hypofractionated and conventional post-mastectomy radiotherapy with or without reconstruction.

Clinical Outcomes of Patients with Metastatic Breast ...

Conclusions: Hypo-fractionated ablative liver RT in patients with MBCa provides safe, tolerable treatment with excellent LC. Keywords: liver ...

Evaluation of Safety of Stereotactic Body Radiotherapy for ...

Standard ablative radiation schedules appear to be safe for patients with oligometastatic disease with 3 to 4 metastases or 2 metastases in close proximity to ...

Advances in breast cancer treatment: a systematic review of ...

Preoperative stereotactic body radiotherapy (SBRT) offers a promising alternative by enabling precise targeting of the tumor itself, as opposed ...