Recruiting

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

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.

ClinicalTrials.gov IDNCT05534438

PhasePHASE2

Enrollment46

SponsorMemorial Sloan Kettering Cancer Center

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Oligometastatic Breast Carcinoma, Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Carcinoma, ER+ Breast Cancer, HER2+ Breast Cancer

About this study

Interventions

Radiation: Stereotactic body radiotherapy — SBRT will be initiated as soon as possible, at not beyond 8 weeks of baseline measurements. Recommended dosing is per department standards for oligometastatic disease (ie, 10 Gy x 3 or 7-8 Gy x 5 fractions daily, excluding weekends and departmental holidays)

Primary outcomes

Progression free survival (3 months from start of SBRT delivery)

Eligibility information

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.

Study locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey 10065 United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey 07748 United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York 11725 United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York 10604 United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York 10065 United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York 11553 United States
Lehigh Valley Health Network (Data Collection Only), Allentown, Pennsylvania 18103 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-01.