Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

Running, not enrolling · Phase 2

Conditions studied: TNBC - Triple-Negative Breast Cancer, Triple Negative Breast Cancer, NSCLC, NSCLC Stage IV, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, NSCLC Stage IV Without EGFR/ALK Mutation

In brief

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

Key facts

Study ID

NCT03808662

Run by

Memorial Sloan Kettering Cancer Center

People needed

107

Starts

2019-01-16

Expected to finish

2027-01-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Willing and able to provide informed consent
• Metastatic disease detected on imaging and histologically confirmed:
• Triple negative breast cancer TNBC (ER <1%, PR <1%, her-2-neu 0- 1+ by IHC or FISH-negative or as determined by MD discretion)
• OR NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement)
• OR Other high-risk breast cancer (per physician's discretion) progressed on hormone or systemic therapy, regardless of ER/HER2 status
• OR NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations with disease progression on first-line tyrosine kinase inhibitor
• Note:
• Biopsy of metastasis prior to enrollment is per treating physician's discretion per standard of care. It is preferred but not required.
• These patients are selected for the study given the similar survival outcomes when given standard of care therapies
• Patient has received at least first-line prior treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies).
• Patients who received prior immunotherapy are allowed.
• Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll.
• Patients with the following medical conditions precluding them from participating in other systemic therapy or drug trials are allowed:
• active liver disease, including viral or other hepatitis, or cirrhosis
• any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months.
• a permanent pacemaker
• a QTc > 480 ms in the baseline EKG
• peripheral neuropathy of grade >/= 2 per NCI CTCAE
• history or known autoimmune disease
• current chronic systemic steroid therapy or any immunosuppressive therapy
• history of primary immunodeficiency or solid organ transplant
• known positive human immunodeficiency virus (HIV), chronic or active hepatitis B or C, or active hepatitis A
• active infection requiring systemic antibiotic therapy
• Patients can have more than 5 metastases but can only have 1-5 oligo-progressive lesions.

You may not qualify if…

• Pregnancy.
• Leptomeningeal disease.
• Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma.
• Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.

Where it is running

• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Rockville Centre — Rockville Centre, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States
• Fred Hutchinson Cancer Research Center (Data Analysis Only) — Seattle, Washington, United States
• Princess Margaret Hospital/Ontario Cancer Institute (Data Analysis Only) — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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