RecruitingNot ApplicableNCT06055881

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

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

Sponsor

Mayo Clinic

Enrollment

45 participants

Start Date

Oct 23, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Carcinoma Metastatic Breast Cancer Anatomic Stage IV Breast Cancer AJCC v8

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria13

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 Criteria10

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.