A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
1 other identifier
interventional
46
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2022
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2022
CompletedStudy Start
First participant enrolled
September 6, 2022
CompletedFirst Posted
Study publicly available on registry
September 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 6, 2026
April 16, 2026
April 1, 2026
4 years
September 6, 2022
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
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.
3 months from start of SBRT delivery
Study Arms (1)
Participants with oligometastatic breast cancer
EXPERIMENTALParticipants 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.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Xu, MD, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2022
First Posted
September 9, 2022
Study Start
September 6, 2022
Primary Completion (Estimated)
September 6, 2026
Study Completion (Estimated)
September 6, 2026
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.