SBRT for Metastatic Breast and Lung Cancer

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

107 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is determine if receiving stereotactic body radiation(SBRT) when participants' metastatic tumors have just begun to grow increase the length of time before disease gets worse

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 SBRT safe for treating metastatic breast and lung cancer?

SBRT (Stereotactic Body Radiotherapy) is generally considered safe for treating various cancers, including lung cancer and metastases, with studies showing an excellent safety profile. However, special care is needed for tumors in ultra-central lung locations due to unique safety considerations. ^{1 2 3 4 5}

How is SBRT different from other treatments for metastatic breast and lung cancer?

Stereotactic Body Radiotherapy (SBRT) is unique because it delivers high doses of radiation with precision to target cancer cells in specific areas, like the lungs or bones, while minimizing damage to surrounding healthy tissue. This approach is particularly beneficial for patients with a limited number of metastases, as it can improve survival rates when combined with standard treatments. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Stereotactic Body Radiotherapy (SBRT) for Metastatic Breast and Lung Cancer?

Research shows that SBRT, a precise form of radiation therapy, can improve survival rates when used alongside standard treatments for patients with certain types of cancer, including breast and lung cancer, that have spread to the bones. It is also effective in treating lung metastases, suggesting it may help control cancer spread and improve outcomes. ^{6 7 9 10 11}

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

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]

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]

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 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]

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]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Outcomes of extra-cranial stereotactic body radiotherapy for metastatic breast cancer: Treatment indication matters. [2021]

2. England 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). [2021]

3. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of stereotactic body radiotherapy versus metastasectomy outcomes in patients with pulmonary metastases. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Pathologic Nodal Staging Before SBRT for Early-stage NSCLC Does Not Impact Overall Survival: A Propensity Score-matched NCDB Analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Multi-institutional phase I/II trial of stereotactic body radiation therapy for lung metastases. [2022]

6. Ireland 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. [2018]

7. China 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. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for the Treatment of Locally Recurrent and Oligoprogressive Non-Small Cell Lung Cancer: A Single Institution Experience. [2022]

9. Ireland 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure. [2022]

11. China 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. [2022]