Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mayo Clinic
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
