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Radiation for Oligoprogressive Metastatic Breast Cancer

This study is looking at whether a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) can help delay the need to change your current systemic therapy (like chemotherapy or hormone therapy) if your metastatic breast cancer (cancer that has spread) starts to progress in a few spots. Researchers also want to see if looking at circulating tumor cells (cancer cells in your blood) can help guide treatment decisions. You might be able to join if you are an adult woman with metastatic breast cancer, have responded well to your current systemic therapy for at least 12 months, and now have 1-3 new or growing cancer spots outside of your brain. The main goal is to see how many people can avoid changing their systemic therapy for at least 6 months. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 45 participants. It is not specified if it is randomized or blinded.
What's involved
You would have blood samples collected, complete surveys, and undergo imaging tests like CT, MRI, and/or PET/CT. You would also receive Stereotactic Body Radiation Therapy (SBRT).
Compensation
Not stated in the trial record.
Follow-up
The study measures how long you can avoid changing systemic therapy for at least 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06055881

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy

Recruiting
NAAges 18+InterventionalTreatment
Mayo Clinic
~45 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:Biospecimen CollectionSurveysStereotactic Body Radiation Therapy (SBRT)Computed TomographyMagnetic Resonance ImagingPositron Emission Tomography

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from a change in systemic therapy (FCST) - overall
Measured over 6 months

Conditions

Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 2 states
Arizona1
Minnesota1

Study leadership

  • Roman O. Kowalchuk, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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.

Exclusion

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
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.

What this trial measures

  • Freedom from a change in systemic therapy (FCST) - overall6 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).