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RecruitingNCT05534438Updated Oct 2, 2026

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

A Phase 2 interventional study of Stereotactic body radiotherapy in Oligometastatic Breast Carcinoma, Breast Cancer and Metastatic Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Updated Oct 2, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • oligometastatic breast cancer
  • breast cancer
  • ER+ Breast Cancer
  • HER2+ Breast Cancer
  • Metastatic Breast Cancer
  • Stereotactic Body Radiation Therapy
  • 22-259
  • Memorial Sloan Kettering Cancer Center
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 46 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    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.

    Radiation: Stereotactic body radiotherapy

Interventions

  • RadiationStereotactic 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)

    Also known as: SBRT

06

What researchers measure

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.

    Time frame: 3 months from start of SBRT delivery

07

Study locations

7 of 8 sites recruiting
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 10065, United States
    • Amy Xu, MD, PhD · Contact · 646-888-6863
    Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    Middletown, New Jersey 07748, United States
    • Amy Xu, MD, PhD · Contact · 646-888-6863
    Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    • Amy Xu, MD, PhD · Contact · 646-888-6863
    Recruiting
  • Memorial Sloan Kettering Commack (Limited Protocol Activities)
    Commack, New York 11725, United States
    • Amy Xu, MD, PhD · Contact · 646-888-6863
    Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    Harrison, New York 10604, United States
    • Amy Xu, MD, PhD · Contact · 646-888-6863
    Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
    • Amy Xu, MD, PhD · Contact · 646-888-6863
    Recruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
    Uniondale, New York 11553, United States
    • Amy Xu, MD, PhD · Contact · 646-888-6863
    Recruiting
  • Lehigh Valley Health Network (Data Collection Only)
    Allentown, Pennsylvania 18103, United States
    • Alyson McIntosh, MD · Contact · 610-402-0700
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 6, 2026→Sep 6, 2027
Oct 2, 2026
Study completion
Sep 6, 2026→Sep 6, 2027
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Primary completion Sep 6, 2026→Sep 6, 2027
    Study completion Sep 6, 2026→Sep 6, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05534438
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Sep 9, 2022
Start date
Sep 6, 2022
Primary completion
Sep 6, 2027 (estimated)
Completion
Sep 6, 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

Amy Xu, MD, PhD
Contact
xua@mskcc.org
646-888-6863
Atif Khan, MD
Contact
khana7@mskcc.org
848-225-6334
Amy Xu, MD, PhD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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