NCT05534438RecruitingPhase 2
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 6 Sept 2022
- Start date
- 6 Sept 2022
- Primary completion date
- 6 Sept 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05534438
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 46
- From 6 Sept 2022 to the primary completion date, 6 Sept 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intracranial disease (including previous intracranial involvement)
- Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
Other illness
- Serious medical comorbidity precluding radiation, including connective tissue disorders
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lehigh Valley Health Network (Data Collection Only) Coordinator of this site? Confirm its status | Allentown | United States | Not yet recruiting |
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Coordinator of this site? Confirm its status | Basking Ridge | United States | Recruiting |
| Memorial Sloan Kettering Commack (Limited protocol activities) Coordinator of this site? Confirm its status | Commack | United States | Recruiting |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) Coordinator of this site? Confirm its status | Harrison | United States | Recruiting |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Coordinator of this site? Confirm its status | Middletown | United States | Recruiting |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) Coordinator of this site? Confirm its status | Montvale | United States | Recruiting |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) Coordinator of this site? Confirm its status | Uniondale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.