SBRT for Metastatic Breast and Lung Cancer

Not currently recruiting at 12 trial locations

Overseen By Iris Zhi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Leptomeningeal disease, 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: Varies

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special type of radiation treatment, called stereotactic body radiotherapy (SBRT), can slow the progression of metastatic breast and lung cancer when tumors resume growth. The trial compares two groups: one receiving SBRT and the other receiving standard care. Individuals with advanced breast or lung cancer, particularly if their cancer has spread and grown despite treatment, might be suitable candidates. This is especially true for those who have undergone at least one round of treatment and have up to five newly growing cancer spots that can be safely treated. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that stereotactic body radiotherapy (SBRT) is likely to be safe for humans?

Research has shown that Stereotactic Body Radiotherapy (SBRT) is generally safe for treating breast and lung cancer that has spread. Studies have found that SBRT effectively targets small tumors in the lungs and other areas, and most patients tolerate this type of radiation therapy well.

Some reports highlight that SBRT is especially safe for small tumors located on the outer edge of the lungs. However, doctors need to exercise caution if the tumor is large or deep inside.

Evidence suggests that SBRT is a promising option for treating certain cancers, with more research supporting its safety and effectiveness. Patients should feel reassured by these findings but should always discuss potential risks with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Stereotactic Body Radiotherapy (SBRT) for metastatic breast and lung cancer because it offers precision targeting of cancer cells with high doses of radiation. Unlike conventional radiotherapy, which typically affects both cancerous and healthy tissues, SBRT focuses radiation directly on the tumor, potentially minimizing damage to surrounding healthy tissue. This targeted approach allows for shorter treatment times, which can lead to quicker recovery and fewer side effects. Additionally, SBRT is particularly promising for treating oligoprogressive sites, where cancer has spread to a limited number of areas, offering a potentially effective option for patients with these specific conditions.

What evidence suggests that stereotactic body radiotherapy (SBRT) might be an effective treatment for metastatic breast and lung cancer?

Research has shown that Stereotactic Body Radiotherapy (SBRT) can effectively treat breast and lung cancers that have spread. In this trial, participants in one arm will receive early SBRT to all oligoprogressive sites. For patients with a limited number of cancer spread areas, SBRT has been shown to extend life compared to those with more widespread cancer. Studies also suggest that SBRT can delay the need for systemic treatments. Evidence indicates that SBRT can prolong the time patients live without cancer progression. Progression-free survival rates with SBRT have ranged from 17% to 57%, indicating that many patients experience a period where their cancer does not grow. ^{2 3 6 7 8}

Who Is on the Research Team?

Nadeem Riaz, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with certain types of metastatic breast or lung cancer that's started to progress. Participants must have had at least one prior systemic therapy and can safely receive radiation. They shouldn't be pregnant, have serious conditions like scleroderma, or uncontrolled medical issues.

Inclusion Criteria

My breast cancer is triple negative.

My lung cancer does not have EGFR, ALK, or ROS1 mutations.

I can receive emergency radiation for symptoms like cord compression before joining the study.

Exclusion Criteria

Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.

I cannot receive radiotherapy due to serious health conditions like ataxia-telangiectasia or scleroderma.

Pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic body radiation therapy (SBRT) to all oligoprogressive sites

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiotherapy/SBRT

Trial Overview

The study tests if stereotactic body radiation therapy (SBRT) can extend the time before disease worsens in patients whose metastatic cancer has begun growing again. It compares SBRT with standard care treatments in a randomized setting.

How Is the Trial Designed?

Group I: Arm 1: Early Stereotactic Body Radiotherapy/SBRT Experimental Treatment 1 Intervention

SBRT to all oligoprogressive sites

Group II: Arm 2:Standard of Care Active Control 1 Intervention

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

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]

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]

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]

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]

In a study of 40 patients with EGFR wild-type oligometastatic non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT), the median overall survival was 40 months, indicating that SBRT can be an effective treatment option for this patient group.

The study found that high-dose radiation (BED10 ≥100 Gy) was associated with better progression-free survival compared to lower doses, and the treatment was well-tolerated, with no severe toxicities reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing efficacy and safety of stereotactic body radiation therapy for oligometastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) wild type. Hu, X., Li, H., Liu, H., et al.[2022]

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 radiotherapy (SBRT) for ultra-central lung tumors shows high efficacy, with pooled local control rates of 92% at 1 year and 89% at 2 years, based on a systematic review of 27 studies involving 1183 treated targets.

While SBRT is effective, it carries risks of severe toxicity, with a 6% incidence of grade 3-4 toxicities and a 4% incidence of treatment-related deaths, highlighting the importance of careful patient selection and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for Ultra-Central lung Tumors: A systematic review and Meta-Analysis and International Stereotactic Radiosurgery Society practice guidelines. Yan, M., Louie, AV., Kotecha, R., et al.[2023]

In a Phase I/II study involving 63 cancer patients, stereotactic body radiotherapy (SBRT) demonstrated a high safety profile with no observed cases of neuropathy or myelopathy during a median follow-up of 21.3 months.

SBRT was effective in controlling spinal metastatic tumors, achieving an 84% tumor progression-free rate at one year, although failures primarily occurred due to recurrence in adjacent bone or the epidural space.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure. Chang, EL., Shiu, AS., Mendel, E., et al.[2022]

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.

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, ...

3.

sciencedirect.com

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

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

This prospective phase II trial highlights safety and efficacy of SBRT for lung and liver OM from primary breast cancer. Whether this or similar local ...

4.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(23)01857-3/abstract

Standard-of-care systemic therapy with or without ...

16 (34%) of 47 patients with breast cancer had triple-negative disease, and 51 (86%) of 59 patients with NSCLC had no actionable driver mutation ...

5.

mdpi.com

mdpi.com/1718-7729/30/7/505

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 ...

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8799217/

Modern evidence and future prospects of external body ...

SBRT is a safe and effective especially for small and peripheral lung metastases. However, if the metastatic lesion is big or centrally located, careful ...

8.

clinicaltrials.gov

clinicaltrials.gov/show/NCT03295916

Stereotactic Body Radiotherapy for Patients With Breast ...

There is growing evidence to support the safety and efficacy of SBRT to many single organ sites, and literature reviews demonstrate LC of 70-90% in OM sites at ...