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

RecruitingPhase 2

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 46 · Started: Sep 6, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05534438

Locations in the U.S.

New JerseyMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
New YorkMemorial Sloan Kettering Commack (Limited Protocol Activities), Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale
PennsylvaniaLehigh Valley Health Network (Data Collection Only), Allentown (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.