Clinical Trials

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.
  • 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 fourthline), 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). Patients with ER negative, PR positive, and HER2 negative disease will also be excluded.
• 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 CNSdirected 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/15/23. Questions regarding updates should be directed to the study team contact.