Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy
NCT ID: NCT06055881
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2023-10-23
2032-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Metastatic Breast Cancer
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).
Biospecimen Collection
Undergo blood sample collection
Surveys
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)
Patients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy .
Computed Tomography
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Magnetic Resonance Imaging
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Positron Emission Tomography
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Interventions
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Biospecimen Collection
Undergo blood sample collection
Surveys
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)
Patients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy .
Computed Tomography
Undergo CT, MRI and/or PET/CT
Magnetic Resonance Imaging
Undergo CT, MRI and/or PET/CT
Positron Emission Tomography
Undergo CT, MRI and/or PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Roman O. Kowalchuk, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2023-03208
Identifier Type: REGISTRY
Identifier Source: secondary_id
22-002943
Identifier Type: OTHER
Identifier Source: secondary_id
GMROR2232
Identifier Type: OTHER
Identifier Source: secondary_id
GMROR2232
Identifier Type: -
Identifier Source: org_study_id