Overview
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.
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.
Eligibility
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.
- 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.
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.