Breast CarcinomaBOSSNCT06055881
Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy
A study testing Biospecimen Collection, Surveys and Stereotactic Body Radiation Therapy (SBRT) in people with Breast Carcinoma and Anatomic Stage IV Breast Cancer AJCC v8, run by Mayo Clinic at 2 sites in United States.
Trial summary
This study assesses if metastasis-directed radiation therapy (Stereotactic body radiation therapy - SBRT) can delay a change in systemic therapy, and if circulating tumor cells in the bloodstream can help guide treatment options in metastatic breast cancer patients with progressive disease Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Cancer
- What is being tested?
- Biospecimen Collection, Surveys and Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Oct 2023to 6 Aug 2031
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Histological confirmation of primary breast cancer.
- Patients with metastatic breast cancer and at least 12 months of clinical response to first-line systemic therapy, with the subsequent development of 1-3 extracranial sites of oligoprogressive disease, and who plan for the continuation of the current systemic therapy.
- NOTE: patients with de novo metastatic disease and those developed metastatic disease after initially localized disease can both be included.
- OR
- Patients with metastatic breast cancer and at least 6 months of clinical response to second-line systemic therapy (or further, e.g., third- or fourth-line), with the subsequent development of 1-3 extracranial sites of oligoprogressive disease.
Show all 13Show fewer
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
- Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
- Ability to complete questionnaire(s) by themselves or with assistance.
- Provide written informed consent.
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
- Willing to provide blood samples for correlative research purposes.
- Receiving radiation therapy as specified in the protocol.
Who cannot join
- Male patients.
- Nursing or pregnant women.
- Men or women of childbearing potential who are unwilling to employ adequate contraception.
- Patients with triple negative disease (negative for ER, PR, and HER2).
- Active second primary malignancy
- More than 3 extracranial sites of oligoprogressive disease
Show all 10Show fewer
- Active CNS disease. Patients with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed.
- Active connective tissue disease that is felt by the treatment team to pose an excess risk of toxicity.
- Prior radiation that overlaps with the intended treatment volume such that, in the opinion of the patient's Radiation Oncologist, radiotherapy to progressing sites will not be safe.
- NOTE: patients with some dose overlap with prior radiotherapy that is deemed safe by the patient's Radiation Oncologist can be included in the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)
This study assesses if metastasis-directed radiation therapy (Stereotactic body radiation therapy - SBRT) can delay a change in systemic therapy, and if circulating tumor cells in the bloodstream can help guide treatment options in metastatic breast cancer patients with progressive disease
- Being tested
- Biospecimen Collection, Surveys, Stereotactic Body Radiation Therapy (SBRT), Computed Tomography, Magnetic Resonance Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Blood Sample Collection
Undergo blood sample collection
SurveysOther
Patients complete the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) survey and "Was it Worth It" questionnaire.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapy
Patients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy .
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT, MRI and/or PET/CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging (MRI), MRI, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo CT, MRI and/or PET/CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, Pet Scan, proton magnetic resonance spectroscopic imaging
Undergo CT, MRI and/or PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast Cancer | Experimental | Breast cancer patients with ER+/PR± (any PR status)/HER2- disease or HER2+ disease (any ER or PR status) will receive radiotherapy that consists primarily of Stereotactic body radiation therapy (SBRT), but at a minimum, it will consist of dose-escalated, moderately hypofractionated radiotherapy (as opposed to conventional fractionation or conventional palliative treatment regimens). Receives: Procedure: Biospecimen Collection; Other: Surveys; Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from a change in systemic therapy (FCST) - overall
FCST is defined as no change in systemic therapy at 6 months after radiotherapy and patient survival at 6 months after radiotherapy. Treatment failure would indicate that there is no longer stability of systemic therapy (and thereby requires a change in systemic therapy to a different agent).
Measured: 6 months
Secondary outcomes (6)
Freedom from a change in systemic therapy (FCST) - ER+/PR±/HER2- (Subgroup A)
Will assess whether metastasis-directed radiotherapy can result in a clinically significant FCST (defined as for at least 6 months) for patients with estrogen receptor+/progesterone receptor±/human epidermal growth factor receptor 2 negative (ER+/PR±/HER2-) disease. The frequency and percentage for FCST rate will be reported, including the 95% confidence interval.
Measured: 6 months
Freedom from a change in systemic therapy (FCST) - HER2 (Subgroup B)
Will assess whether metastasis-directed radiotherapy can result in a clinically significant FCST (defined as for at least 6 months) for patients with human epidermal growth factor receptor 2 positive (HER2+) disease. The frequency and percentage for FCST rate will be reported, including the 95% confidence interval.
Measured: 6 months
Progression-free survival (PFS)
Will assess the impact of metastasis-directed radiotherapy on PFS in the setting of oligoprogressive breast cancer. PFS is defined as the time from completion of radiotherapy to the first of either disease progression or death from any cause. Medians and 95% confidence intervals will be reported.
Measured: Up to 5 years
Overall survival (OS)
Will explore the impact of metastasis-directed radiotherapy on overall survival (OS) in the setting of oligoprogressive breast cancer. OS is defined as the time from completion of radiotherapy to death from any cause. Medians and 95% confidence intervals will be reported.
Measured: Up to 5 years
Quality of life - EQ-5D-5L
The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a patient-reported outcome measure used to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated on a score of 1-5 where 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems/unable to perform the task. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state.
Measured: Up to 5 years
Determine the local control of irradiated, oligoprogressive lesions
This rate will be reported as a percentage with a 95% confidence interval.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start23 Oct 2023
- Primary completion26 Oct 2026 (estimated)
- Study completion6 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman O. Kowalchuk, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055881
- Sponsor's protocol ID
- GMROR2232
- Other IDs
- NCI-2023-03208, 22-002943, GMROR2232
- Acronym
- BOSS
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)
- ClinicalTrials.gov ID
- NCT06055881
- Acronym / sponsor ID
- BOSS / GMROR2232
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 26 Oct 2026 (estimated)
- Study completion
- 6 Aug 2031 (estimated)
- First posted
- 28 Sep 2023 (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.
This study assesses if metastasis-directed radiation therapy (Stereotactic body radiation therapy - SBRT) can delay a change in systemic therapy, and if circulating tumor cells in the bloodstream can help guide treatment options in metastatic breast cancer patients with progressive disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast Cancer | Experimental | Procedure: Biospecimen Collection, Other: Surveys, Radiation: Stereotactic Body Radiation Therapy (SBRT), Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission TomographyBreast cancer patients with ER+/PR± (any PR status)/HER2- disease or HER2+ disease (any ER or PR status) will receive radiotherapy that consists primarily of Stereotactic body radiation therapy (SBRT), but at a minimum, it will consist of dose-escalated, moderately hypofractionated radiotherapy (as opposed to conventional fractionation or conventional palliative treatment regimens). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years.
- Histological confirmation of primary breast cancer.
- Patients with metastatic breast cancer and at least 12 months of clinical response to first-line systemic therapy, with the subsequent development of 1-3 extracranial sites of oligoprogressive disease, and who plan for the continuation of the current systemic therapy.
- OR
- Patients with metastatic breast cancer and at least 6 months of clinical response to second-line systemic therapy (or further, e.g., third- or fourth-line), with the subsequent development of 1-3 extracranial sites of oligoprogressive disease.
Key exclusion criteria (10 listed)
- Male patients.
- Nursing or pregnant women.
- Men or women of childbearing potential who are unwilling to employ adequate contraception.
- Patients with triple negative disease (negative for ER, PR, and HER2).
- Active second primary malignancy
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Blood Sample CollectionUndergo blood sample collection | Procedure or surgery | Metastatic Breast Cancer |
| SurveysPatients complete the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) survey and "Was it Worth It" questionnaire. | Other | Metastatic Breast Cancer |
| Stereotactic Body Radiation Therapy (SBRT)Also: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapyPatients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy . | Radiation | Metastatic Breast Cancer |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT, MRI and/or PET/CT | Procedure or surgery | Metastatic Breast Cancer |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging (MRI), MRI, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo CT, MRI and/or PET/CT | Procedure or surgery | Metastatic Breast Cancer |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, Pet Scan, proton magnetic resonance spectroscopic imagingUndergo CT, MRI and/or PET/CT | Procedure or surgery | Metastatic Breast Cancer |
Primary outcome
Freedom from a change in systemic therapy (FCST) - overall
Time frame: 6 months
FCST is defined as no change in systemic therapy at 6 months after radiotherapy and patient survival at 6 months after radiotherapy. Treatment failure would indicate that there is no longer stability of systemic therapy (and thereby requires a change in systemic therapy to a different agent).
6 secondary outcomes
Freedom from a change in systemic therapy (FCST) - ER+/PR±/HER2- (Subgroup A)
Time frame: 6 months
Freedom from a change in systemic therapy (FCST) - HER2 (Subgroup B)
Time frame: 6 months
Progression-free survival (PFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Quality of life - EQ-5D-5L
Time frame: Up to 5 years
Determine the local control of irradiated, oligoprogressive lesions
Time frame: Up to 5 years
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 3 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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. This study is not recruiting at the moment.
Roman O. Kowalchuk, MD principal investigator
Mayo Clinic in Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Surveys and Stereotactic Body Radiation Therapy (SBRT) in people with Breast Carcinoma and Anatomic Stage IV Breast Cancer AJCC v8, run by Mayo Clinic at 2 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 13 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from a change in systemic therapy (FCST) - overall (time frame: 6 months). 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 3 Sep 2026.