Adding targeted radiation therapy to drug treatment for breast cancer
Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
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 |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Trial ID | NCT05534438 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using targeted radiation therapy for metastatic cancers, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Basking Ridge, New Jersey and 7 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.