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

Not Applicable

Recruiting

• Conditions: Breast Carcinoma; Metastatic Breast Cancer; Anatomic Stage IV Breast Cancer AJCC V8
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06055881
• Lead Sponsor: Mayo Clinic

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 help guide treatment options in metastatic breast cancer patients with progressive disease

Detailed Description

PRIMARY OBJECTIVE:

I. To assess whether radiotherapy can provide clinically significant freedom from a change in systemic therapy (defined as for at least 6 months) for well-selected patients with oligoprogressive metastatic breast cancer.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and complete questionnaires on study.

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-09-28
• Study Start: 2023-10-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 45

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.
• 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

• > 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo blood sample collection and complete questionnaires on study.

Primary Outcome Measures

Name	Time	Method
Freedom from a change in systemic therapy	6 months	Freedom from a change in systemic therapy 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).

Trial Locations

Locations (2)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States