Actively Recruiting
Stereotactic Body Radiation Therapy to Extend Systemic Therapy Benefit in Patients With Solitary Breast Cancer Progression
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-16
46
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using Stereotactic Body Radiation Therapy (SBRT) to treat a single metastatic site where breast cancer has worsened may be an effective approach for people with oligometastatic breast cancer. Participants will continue their usual drug therapy while receiving SBRT. This combination is being studied to see if it can prevent the cancer from worsening at other sites or spreading further. Participants with oligometastatic breast cancer who have isolated progression after at least 6 months of response to systemic therapy will receive image-guided SBRT targeted at the progressive lesion seen on imaging. SBRT dosing follows standard department protocols for oligometastatic disease, typically 10 Gy for 3 fractions or 7-8 Gy for 5 daily fractions excluding weekends and holidays. Systemic therapy will be paused during radiation days and resumed afterward. During the study, participants will be monitored for progression-free survival starting from the beginning of SBRT treatment, with assessments at 3 months. Researchers will evaluate the effect of adding SBRT to ongoing drug therapy on cancer progression. Participants will undergo regular imaging and clinical evaluation while continuing their usual care. The total duration of participation varies based on individual treatment schedules and follow-up assessments.
CONDITIONS
Brief Title
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Willing and able to provide informed consent
- Biopsy-proven metastatic breast cancer
- ER+/HER2- with more than 5% ER+ staining, or HER2+ including low and high expressors
- History of at least 6 months sustained response to systemic therapy without progression
- Isolated site of disease progression on FDG PET scan
- ECOG performance status 0 or 1
You will not qualify if you...
- Pregnancy
- Serious medical conditions that prevent radiation, including connective tissue disorders
- Intracranial disease, including previous brain involvement
- Previous radiotherapy to the treatment site that prevents safe radiation planning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks from baseline measurements
Participants receive stereotactic body radiotherapy (SBRT) to the progressive lesion while maintaining their existing systemic therapy, which is paused during radiation days and resumed after completion.
Daily visits for 3 to 5 radiation sessions excluding weekends and holidays
Duration - At least 3 months from start of SBRT delivery
Participants are monitored for progression-free survival starting from the start of SBRT delivery.
Periodic visits as per clinical follow-up
Trial Site Locations
Total: 8 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 10065
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
8
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, United States, 18103
Not Yet Recruiting
Research Team
A
Amy Xu, MD, PhD
A
Atif Khan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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