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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06055881
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Surveys — OTHER
    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
    Patients receive stereotactic body radiation therapy (SBRT), metastasis-directed radiation therapy .
  • Computed Tomography — PROCEDURE
    Undergo CT, MRI and/or PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo CT, MRI and/or PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo CT, MRI and/or PET/CT

Study Details

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

Key Dates

Start date
Oct 23, 2023
Status verified
Feb 2026
Primary completion
May 1, 2027
Completion
May 1, 2032

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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).

Primary Outcome Measure

Freedom from a change in systemic therapy (FCST) - overall [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Sarah E. James, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Roman O. Kowalchuk, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

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Breast cancer
By specialty
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By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Rochester· Rochester, MN

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