SBRT with Standard Treatment for Metastatic Breast or Lung Cancer
This study is investigating if adding Stereotactic Body Radiotherapy (SBRT), a type of focused radiation, to your usual cancer treatment (Standard of Care Systemic Therapy) can help people with breast or lung cancer that has spread. The goal is to see if this combination increases the time before your cancer gets worse. You might be eligible if you have metastatic breast cancer (all types) or non-small cell lung cancer that has spread, especially if you've had progression on certain targeted therapies. The study is looking for about 145 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. The study aims to enroll 145 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be measured for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03808337
Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~145 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Stereotactic Body Radiotherapy/SBRTSystemic Therapy/Standard of Care
At a glance
Recruiting sites
11 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival
Measured over Up to 2 years
Conditions
Where it's being run
12 sites across 6 statesNew York4
New Jersey3
Connecticut2
California1
Florida1
Pennsylvania1
Study leadership
- Amy Xu, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Metastatic disease detected on imaging and histologically confirmed
Metastatic breast cancer (all subtypes)
Non-small cell lung cancer (NSCLC) without known targetable molecular alterations in EGFR, ALK, or ROS1
NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations who had a history of disease progression on first-line tyrosine kinase inhibitor
Patient can either have newly diagnosed metastatic disease, or have non-progressive disease on systemic therapy (for at least 3 months on systemic imaging)
Patients must have measurable disease at baseline (RECIST or PERCIST 2.0) and with 5 or fewer discrete disease sites that are technically amendable to SBRT (with the exception that if the primary disease is not amendable to SBRT it is allowed to be treated with conventionally fractionated or hypfractionated radiotherapy).
Two lesions in such close proximity to one another that treatment with one isocenter is more accurate and safer in the liver, lungs, or other similar anatomic locations should be viewed as one site of metastatic disease treatment
Disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal extension) can represent one site of disease in the spine; non-contiguous lesions in vertebral bodies separated by one vertebral body free of disease should be viewed as 2 sites of treatment
If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
For de novo stage IV patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy. If the primary tumor or other locoregional disease has not been definitively treated and is not amendable to SBRT, it must be treated with conventionally fractionated or hypofractionated radiotherapy using a regimen that delivers a minimum BED of 48 Gy10. If the clinical scenario deem that other forms of local therapy may be more suitable for the primary and locoregional disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
If primary disease was previously treated with local therapy in the form of surgery or radiation, any new local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation. If the clinical scenario deem that other forms of local therapy may be more suitable for the local/regional recurrent disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
Patients may receive palliative radiotherapy for symptomatic metastases or primary disease prior to enrollment provided that there is at least one other non-irradiated lesion amenable to SBRT at the time of enrollment.
Patients with brain metastases are eligible if these lesions have been treated prior to enrollment.
ECOG Performance status 0 - 2.
Age \>/= 18 years.
Able to provide informed consent.
Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 60 years old or no menses for 1\> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
Adequate baseline organ function to allow SBRT to all relevant targets, as determined by the treating radiation oncologist based on lesion location, lesion size, and proximity to relevant organs at risk.
Exclusion
Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator.
Pregnant or lactating women.
Other active malignancy within the last year, even if without evidence of disease.
Clinical or radiological evidence of spinal cord compression
Malignant pleural effusion or ascites.
Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
What this trial measures
- Progression Free SurvivalUp to 2 years
To determine whether stereotactic body radiotherapy to all sites of metastatic disease in patients with oligometastatic non-small cell lung cancer or triple-negative breast cancer improves progression free survival (PFS), defined as time from randomization to disease progression or death, as compared to standard of care therapy alone.