A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
NCT ID: NCT05534438
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2022-09-06
2026-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants with oligometastatic breast cancer
Participants with oligometastatic breast cancer with isolated progression after sustained (\>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of 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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Amy Xu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Alyson McIntosh, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-259
Identifier Type: -
Identifier Source: org_study_id
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