Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06055881

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

Led by Mayo Clinic · Updated on 2026-02-06

45

Participants Needed

2

Research Sites

444 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63; 18 years
  • Histological confirmation of primary breast cancer
  • Metastatic breast cancer with at least 12 months of response to first-line systemic therapy followed by 1-3 extracranial oligoprogressive sites, planning to continue current systemic therapy
  • Metastatic breast cancer with at least 6 months of response to second-line or later systemic therapy, with 1-3 extracranial oligoprogressive sites
  • ECOG Performance Status 64; 2
  • Negative urine or serum pregnancy test 64; 7 days prior to registration for women of childbearing potential
  • Ability to complete questionnaires independently or with help
  • Provide written informed consent
  • Willingness to return for follow-up during the Active Monitoring Phase
  • Willing to provide blood samples for research
  • Receiving radiation therapy as specified in the protocol
Not Eligible

You will not qualify if you...

  • Male patients
  • Nursing or pregnant women
  • Men or women of childbearing potential unwilling to use adequate contraception
  • Patients with triple negative breast cancer (negative for ER, PR, and HER2)
  • Active second primary cancer
  • More than 3 extracranial sites of oligoprogressive disease
  • Active central nervous system disease, except stable and treated asymptomatic CNS lesions without recent corticosteroids
  • Active connective tissue disease posing excessive risk of toxicity
  • Prior radiation overlapping intended treatment area deemed unsafe by Radiation Oncologist
  • Note: Some prior radiation overlap considered safe by Radiation Oncologist allowed

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Mayo Clinic in Arizona

Scottsdale, Arizona, United States, 85259

Actively Recruiting

2

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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