At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Stereotactic Body Radiotherapy and Surgery for Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8 and 8 related conditions. Completed, enrolled 129 participants across 162 sites in 4 countries.
Detailed Summary
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.
Study Details
Timeline
Interventions
Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy.
All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.