Adding targeted radiation therapy to drug treatment for breast cancer
Official title: Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
Run by Memorial Sloan Kettering Cancer Center · NCT05534438 · Data updated 2026-11-12
This study is testing whether adding targeted radiation therapy to regular drug treatment can help people with a specific type of breast cancer keep their disease from getting worse or spreading.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Status | Recruiting |
| Started | September 6, 2022 |
| Main results expected | September 6, 2027 |
| Study ends | September 6, 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT05534438 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older with biopsy-proven metastatic breast cancer who have a sustained response to systemic therapy and an isolated site of disease progression.
✕Probably not a fit
Patients with serious medical comorbidities, previous radiation to the treatment site, or those with intracranial disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of Stereotactic Body Radiation Therapy (SBRT) in treating a single metastatic site in patients with oligometastatic breast cancer while they continue their usual drug therapy. The goal is to determine if this combination can prevent cancer from worsening or spreading to other sites. Participants must have a sustained response to systemic therapy and an isolated site of disease progression. The study is being conducted at Memorial Sloan Kettering Cancer Center locations in New Jersey.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with oligometastatic breast cancer by preventing disease progression.
How similar studies have gone: Other studies have shown promise in using targeted radiation therapy for metastatic cancers, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Willing and able to provide informed consent * Metastatic breast cancer, biopsy proven * ER+/HER2-, defined as \>5% ER+ staining * HER2+ (regardless of ER status), including HER2-low and high expressors * History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression) * Isolated site of disease progression on FDG PET scan * Consented to 12-245 * ECOG performance status 0-1 Exclusion Criteria: * Pregnancy * Serious medical comorbidity precluding radiation, including connective tissue disorders * Intracranial disease (including previous intracranial involvement) * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
Where it's running
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States Recruiting -
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States Recruiting -
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States Recruiting -
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States Recruiting -
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States Recruiting
Show 2 more locations
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States Recruiting -
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, United States Not yet recruiting
Study contacts
- Principal investigator: Amy Xu, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Amy Xu, MD, PhD
- Email: xua@mskcc.org
- Phone: 646-888-6863
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.