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NCT05534438PHASE2Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

9/6/2022

Completion Date

9/6/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

RADIATION

Stereotactic body radiotherapy

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Conditions

Oligometastatic Breast CarcinomaBreast CancerMetastatic Breast CancerMetastatic Breast CarcinomaER+ Breast CancerHER2+ Breast Cancer

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