Oligometastatic Breast CarcinomaPhase 2NCT05534438
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 study testing Stereotactic body radiotherapy in people with Oligometastatic Breast Carcinoma and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Breast Carcinoma, Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Sep 2022to 6 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- Isolated site of disease progression on FDG PET scan
- Consented to 12-245
- ECOG performance status 0-1
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, 18103
Alyson McIntosh, MD, 610-402-0700
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 10065
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Amy Xu, MD, PhD, 646-888-6863
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Amy Xu, MD, PhD, 646-888-6863
About this study
Official title: Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
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.
- Conditions
- Oligometastatic Breast Carcinoma, Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Carcinoma, ER+ Breast Cancer, HER2+ Breast Cancer
- Being tested
- Stereotactic body radiotherapy
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapyRadiation
Also called SBRT
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)
| Study group | Role | What they receive |
|---|---|---|
| Participants with oligometastatic breast cancer | Experimental | 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. Receives: Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months from start of SBRT delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start6 Sep 2022
- Primary completion6 Sep 2027 (estimated)
- Study completion6 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Xu, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534438
- Sponsor's protocol ID
- 22-259
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
- ClinicalTrials.gov ID
- NCT05534438
- Acronym / sponsor ID
- 22-259
- Conditions
- Oligometastatic Breast Carcinoma, Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Carcinoma, ER+ Breast Cancer, HER2+ Breast Cancer
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 6 Sep 2027 (estimated)
- Study completion
- 6 Sep 2027 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with oligometastatic breast cancer | Experimental | Radiation: Stereotactic body radiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older
- Willing and able to provide informed consent
- Metastatic breast cancer, biopsy proven
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic body radiotherapyAlso: SBRTSBRT 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) | Radiation | Participants with oligometastatic breast cancer |
Primary outcome
Progression free survival
Time frame: 3 months from start of SBRT delivery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Xu, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic body radiotherapy in people with Oligometastatic Breast Carcinoma and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Xu, MD, PhD (646-888-6863, xua@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 3 months from start of SBRT delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.