SBRT + Standard of Care for Metastatic Breast Cancer

Recruiting at 17 trial locations

Overseen By Amy Xu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Active malignancy, Spinal cord compression, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Concurrent with SBRT

145 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a targeted radiation treatment called stereotactic body radiotherapy (SBRT) to standard care can prevent metastatic breast cancer from worsening. It targets individuals with up to five cancer spots in the body. The trial is open to those with confirmed metastatic breast cancer or specific types of lung cancer that have spread but are stable. This trial might be suitable for those dealing with cancer that has spread and are interested in this new combination. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Stereotactic Body Radiotherapy (SBRT) is generally safe for treating oligometastatic cancers, where cancer has spread to a few areas. One study found that standard doses were safe, with no serious side effects linked to the treatment. Another study confirmed that SBRT is a safe option for patients with metastatic breast cancer, effectively preventing cancer from returning in the treated areas. Additionally, some patients experienced moderate side effects, but more serious side effects were less common. Overall, these studies suggest that SBRT is well-tolerated with manageable side effects for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Stereotactic Body Radiotherapy (SBRT) with standard systemic therapies for metastatic breast cancer because SBRT offers a unique advantage. Unlike traditional radiation that targets broader areas, SBRT delivers high doses of radiation with precision to specific metastatic sites, potentially minimizing damage to surrounding healthy tissues. This precise approach might enhance the effectiveness of concurrent systemic therapies like chemotherapy or targeted treatments, which are the current standard of care. By simultaneously targeting all known metastases, SBRT could potentially improve patient outcomes more efficiently than existing treatments alone.

What evidence suggests that SBRT + Standard of Care could be effective for metastatic breast cancer?

Research has shown that stereotactic body radiotherapy (SBRT) can effectively treat metastatic breast cancer. In this trial, one group of participants will receive SBRT alongside standard care therapies. Studies have found that patients with oligometastases (cancer spread to only a few small areas) who receive SBRT tend to live longer than those with more widespread cancer. A follow-up study revealed that most patients treated with SBRT experienced good results for up to about 15 months. SBRT can safely target small areas where cancer has spread, potentially delaying the need for more extensive treatments. Additionally, SBRT can postpone the need to change treatment plans by over a year, providing patients more time before requiring new therapies. ^{4 6 7 8 9}

Who Is on the Research Team?

Amy Xu, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with certain types of breast or non-small cell lung cancer that has spread (1-5 metastases). They should be able to undergo SBRT, have a performance status of 0-2, and not be pregnant. Excluded are those with serious health issues preventing radiotherapy, spinal cord compression signs, malignant effusions, another active cancer in the last year.

Inclusion Criteria

I am able to care for myself and perform daily activities.

I have two cancer lesions close together, treated as one.

I am a woman who cannot become pregnant or have tested negative for pregnancy.

Exclusion Criteria

Pregnant or lactating women

Joining this trial will not delay my current treatment plan.

You have other serious health problems that might make it unsafe for you to receive radiotherapy, as determined by your doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Body Radiotherapy (SBRT) to all known metastases and continue standard of care therapy

Concurrent with SBRT

Follow-up

Participants are monitored for progression free survival and overall survival

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiotherapy/SBRT
• Systemic Therapy/Standard of Care

Trial Overview The study tests if adding Stereotactic Body Radiotherapy (SBRT) to standard systemic therapy prolongs the time before worsening of metastatic breast or non-small cell lung cancer. It targets patients with limited sites of disease amenable to this precise radiation technique.

How Is the Trial Designed?

Group I: Stereotactic Body Radiotherapy (SBRT) + Standard of Care Experimental Treatment 2 Interventions

Patients enrolled on Arm 2 of the study will undergo Stereotactic Body Radiotherapy/SBRT to all known metastases seen on imaging studies performed prior to enrollment. Radiotherapy will be given concurrently to all metastatic sites. Minimum BED for ablative SBRT is more than or equal to 48 Gy10. Patients can undergo systemic therapy concurrently with SBRT at the discretion of treating radiation oncologist and medical oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.

Group II: Standare of Care Active Control 1 Intervention

Patients with newly diagnosed metastatic non-small cell lung cancer or triple negative breast cancer may be enrolled on protocol prior to receiving any systemic therapy. If these patients are randomized to the standard of care arm (Arm 1), they will initiate appropriate therapy as determined by their oncologist. Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) for metastatic breast cancer showed high local control rates of 89% at 1 year and 86.6% at 2 years, indicating its effectiveness in managing metastatic lesions.

Patients with oligometastases had significantly better overall survival (83.5% at 1 year) and progression-free survival (66% at 1 year) compared to those with oligoprogression or local control of dominant tumor, suggesting that SBRT can delay the need for chemotherapy or hormonal therapy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of extra-cranial stereotactic body radiotherapy for metastatic breast cancer: Treatment indication matters. Tan, H., Cheung, P., Louie, AV., et al.[2021]

Stereotactic Body Radiation Therapy (SBRT) demonstrated excellent local control rates of 98% at 1 year and 90% at 2 and 3 years in 33 patients with oligometastatic breast cancer, indicating its efficacy in managing limited metastatic disease.

The treatment was well tolerated with no severe toxicities (G3-4), suggesting that SBRT is a safe option for patients with 1-3 lung and liver lesions who are not candidates for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy: A promising chance for oligometastatic breast cancer. Scorsetti, M., Franceschini, D., De Rose, F., et al.[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) effectively delays the need for subsequent systemic treatment in patients with oligoprogressive breast cancer, with a median time to next systemic treatment of 8 months based on a study of 79 patients.

The study found that a higher biological effective dose (BED) of SBRT (>70Gy10) significantly improved freedom from local progression (86.7% overall), indicating that treatment intensity can influence outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy (SBRT) and concomitant systemic therapy in oligoprogressive breast cancer patients. Nicosia, L., Figlia, V., Ricottone, N., et al.[2022]

A systematic review highlighted the safety concerns and toxicity profiles of combining stereotactic body radiotherapy (SBRT) with targeted therapy or immunotherapy in patients with metastatic cancer, particularly those with oligometastatic disease.

An international consensus among 28 experts provided guidelines on risk mitigation strategies, including recommendations for potential interruptions in therapy and adjustments in radiation dosing, to enhance the safety of this combined treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastases-directed stereotactic body radiotherapy in combination with targeted therapy or immunotherapy: systematic review and consensus recommendations by the EORTC-ESTRO OligoCare consortium. Kroeze, SGC., Pavic, M., Stellamans, K., et al.[2023]

This multicenter randomized phase III trial aims to determine if combining Stereotactic Body Radiation Therapy (SBRT) with standard systemic treatment improves progression-free survival in patients with solid tumors and up to 3 bone-only metastases, with a total of 196 patients expected to be enrolled over 4 years.

The primary goal is to assess progression-free survival at 1 year, while secondary outcomes will evaluate local control, cancer-specific survival, quality of life, and pain management, highlighting the potential for SBRT to enhance patient outcomes by controlling bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of extracranial stereotactic body radiation therapy (SBRT) added to standard treatment in patients with solid tumors (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases: study protocol for a randomised phase III trial (STEREO-OS). Thureau, S., Marchesi, V., Vieillard, MH., et al.[2021]

High-dose stereotactic body radiation therapy (SBRT) demonstrated a 100% local control rate at one year and 96% at two years for patients with one to three lung metastases, indicating its efficacy in managing these tumors.

The treatment was well-tolerated, with only 8% of patients experiencing grade 3 toxicity and no grade 4 toxicity reported, suggesting a favorable safety profile for high-dose SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional phase I/II trial of stereotactic body radiation therapy for lung metastases. Rusthoven, KE., Kavanagh, BD., Burri, SH., et al.[2022]

Stereotactic body radiotherapy (SBRT) is being increasingly considered for patients with oligometastatic breast cancer, which is defined as having 5 or fewer metastatic sites, as it may improve their prognosis through aggressive local treatment.

A survey of Canadian Medical Oncologists was conducted to understand their beliefs and opinions about the use of SBRT in this patient group, highlighting the need to identify the optimal scenarios for its implementation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes and beliefs toward the use of stereotactic body radiotherapy in oligometastatic breast cancer: A commentary on a survey of Canadian Medical Oncologists. Donovan, E., Dhesy-Thind, S., Mukherjee, S., et al.[2020]

Stereotactic body radiation therapy (SBRT) has a significant impact on improving metastatic progression-free survival and overall survival in patients with oligometastatic or oligoprogressive cancers.

This review aims to clarify the role of SBRT in the treatment pathway for these patients, highlighting its potential benefits in managing cancer spread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of oligometastatic or oligoprogression cancer]. Bourgier, C., Latorzeff, I., Fenoglietto, P., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11609137/

Treatment of metastatic breast cancer by stereotactic body ... Patients administered local ablative radiotherapy (SBRT/SRS) for oligometastases have better overall survival than those treated for oligoprogression.

2. 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.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0936655524005429

Patient Perspectives on the Value of Stereotactic Body ... This study aims to understand which outcomes are most important to patients when considering SBRT as a treatment option.

4. 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, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12329079/

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 ...

6. 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 ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814024001622

Definitive results of a prospective non-randomized phase 2 ... Conclusion. SBRT is a safe and valid option in oligometastatic breast cancer patients, with very high rates of local control. An optimal selection of patients ...

8. 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, ...

9. 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 ... Local control was achieved in 85% of patients [n=17]. Median OS was 2.7 years [IQR: 0.1-6.8 years]. Grade 2 toxicity [n=9, 45%] and grade 3 ...