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

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.

Inclusion Criteria:

• Pathologically confirmed metastatic breast cancer within 270 days prior to registration
• Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis
• =< 2 metastases seen on standard imaging within 30 days prior to registration
• Controlled primary tumor site defined as >= 3 months (90 days) recurrence-free interval since completion of definitive surgical management
• All known disease amenable to metastasis-directed therapy with either SBRT or resection
◦ NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered
◦ NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites
◦ NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy
• Maximum diameter of individual metastasis in any dimension =< 5 cm
• Metastases must be > 5 cm away from each other (defined as Edge to Edge of tumor)
◦ NOTE: If metastases are =< 5 cm away from each other, consider enrollment in NRG-BR001
• First-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2 or other standard targeted therapy) for metastatic breast cancer not to have exceeded a duration of 6 months at the time of registration
• Appropriate stage for study entry based on the following diagnostic workup:
◦ History/physical examination within 30 days prior to registration
◦ Computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 30 days prior to study registration

Phase II/III
Paul Montgomery, M.D.
Nikki Moxon

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.