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

Recruiting now · Not applicable

Conditions studied: Breast Carcinoma, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Cancer

In brief

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 facts

Study ID

NCT06055881

Run by

Mayo Clinic

People needed

45

Starts

2023-10-23

Expected to finish

2032-05-01

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States (enrolling)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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