Radiation zaps spots to keep chemo working longer
NCT ID NCT06055881
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 4 times
Summary
This study tests whether precisely targeted radiation (SBRT) can treat a few growing cancer spots in patients with metastatic breast cancer, allowing them to stay on their current systemic therapy instead of switching to a new drug. Researchers will also look at whether circulating tumor cells in the blood can help guide treatment decisions. The trial enrolls 45 adults with stable disease for at least 12 months who develop 1-3 new progressive sites.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this approach could allow patients to stay on their current systemic therapy longer, delaying the need for a new drug regimen.
- What could go wrong
- This is a small, early-phase study (45 participants) with no control group, so results may not apply broadly. Radiation may not effectively control all progressive sites, and side effects from SBRT are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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45 people
The number who actually took part.
- Started
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Oct 2023
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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