Targeted Radiation for Metastatic Breast Cancer

This study is looking at whether adding precisely targeted radiation therapy, called Stereotactic Body Radiation Therapy (SBRT), to your usual drug treatment can help people with breast cancer that has spread (metastatic breast cancer). Specifically, it's for those with "oligometastatic" breast cancer, meaning the cancer has spread to only a few places, and one of those spots has worsened. You would continue your current drug therapy while receiving SBRT. Researchers want to see if this combination can stop the cancer from getting worse in other areas or spreading further. The study plans to include 46 participants and is looking for people aged 18 or older with biopsy-proven metastatic breast cancer, including ER+ (estrogen receptor positive) and HER2+ (human epidermal growth factor receptor 2 positive) types. Success will be measured by how long participants live without their cancer progressing, checked at 3 months after SBRT begins. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 46 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will receive SBRT to a single metastatic site while continuing their usual drug therapy. SBRT will be given over 3 or 5 daily sessions, excluding weekends and holidays.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure progression-free survival at 3 months from the start of SBRT delivery.

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NCT05534438

A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~46 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Stereotactic body radiotherapy

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival
Measured over 3 months from start of SBRT delivery
Oligometastatic Breast Carcinoma
Breast Cancer
Metastatic Breast Cancer
Metastatic Breast Carcinoma
ER+ Breast Cancer
HER2+ Breast Cancer
8 sites across 3 states
New York4
New Jersey3
Pennsylvania1
  • Amy Xu, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

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

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.
  • Progression free survival3 months from start of SBRT delivery

    The primary objective is to assess progression free survival, defined as systemic progression or death, within 3 months from start of Stereotactic Body Radiation Therapy/SBRT delivery.