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

Mayo Clinic

Status: Enrolling

Conditions: Anatomic Stage IV Breast Cancer AJCC V8; Metastatic Breast Cancer; Breast Carcinoma

Treatments: Other: Surveys; Procedure: Positron Emission Tomography; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Stereotactic Body Radiation Therapy (SBRT); Procedure: Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06055881

NCI-2023-03208 (Registry Identifier)

22-002943 (Other Identifier)

GMROR2232 (Other Identifier)

Details and patient eligibility

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

Enrollment: 45 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Metastatic Breast Cancer

Experimental group

Description:

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).

Treatment:

Procedure: Magnetic Resonance Imaging

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Procedure: Positron Emission Tomography

Procedure: Computed Tomography

Procedure: Biospecimen Collection

Other: Surveys