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RecruitingPhase 2NCT03808337

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

◆ AI Clinical Summary

This study tests whether adding a specialized radiation treatment called SBRT (stereotactic body radiotherapy) to standard cancer treatment can help triple negative breast cancer patients live longer without their disease getting worse. SBRT is a focused radiation technique that targets cancer spots throughout the body rather than just the original tumor site.

Key Objective:The trial is testing whether SBRT combined with standard treatment can delay disease progression in patients with triple negative breast cancer that has spread to 1-5 locations in the body.

Who to Consider:Patients with triple negative breast cancer that has spread to 1-5 sites beyond the original tumor and who are eligible for standard cancer treatment should consider this trial.

Trial Parameters

ConditionTriple Negative Breast Cancer
SponsorMemorial Sloan Kettering Cancer Center
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment145
SexALL
Min Age18 Years
Max AgeN/A
Start Date2019-01-16
Completion2027-01
Interventions
Stereotactic Body Radiotherapy/SBRTSystemic Therapy/Standard of Care

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Brief Summary

This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.

Eligibility Criteria

Inclusion Criteria: * 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, lung

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