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RecruitingInterventional

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

NCT ID: NCT06055881Sponsor: Mayo ClinicLast updated: 2026-02-06

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

Arms & interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

  • OtherSurveys

    Patients complete the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) survey and "Was it Worth It" questionnaire.

  • RadiationStereotactic Body Radiation Therapy (SBRT)

    Patients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy .

  • ProcedureComputed Tomography

    Undergo CT, MRI and/or PET/CT

  • ProcedureMagnetic Resonance Imaging

    Undergo CT, MRI and/or PET/CT

  • ProcedurePositron Emission Tomography

    Undergo CT, MRI and/or PET/CT

Outcome measures

Primary

  • 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).

    Time frame: 6 months

Secondary

  • 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

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

Recruiting
Clinical Trials Referral Office · Contact
Sarah E. James, M.D., Ph.D. · Principal Investigator

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trials Referral Office · Contact
Roman O. Kowalchuk, MD · Principal Investigator
Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy | Cancerify