Status:
RECRUITING
Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2032
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06055881
Start Date
October 23 2023
End Date
May 1 2032
Last Update
November 10 2025
Active Locations (2)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905