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Breast
General Information
Study Name:
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
Age Group:
Adult
Protocol Number:
NCT02364557
Background Information:
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.
Offered at:
Inova Fairfax Medical Campus
3300 Gallows Road
Falls Church, Virginia 22042-3300
Inova Fair Oaks Hospital
3600 Joseph Siewick Dr
Fairfax, VA 22033
Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital
Fair Oaks Office
3580 Joseph Siewick Drive, Suite 403
Fairfax, VA 22033
Eligibility Information
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
Additional eligibility criteria in protocol.
Ineligibility Information
Pathologic evidence of local/regional breast tumor recurrence
Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years
Metastases with indistinct borders making targeting not feasible
Additional ineligibility criteria in protocol.
Contact Information
Contact Name:
Inova Breast Cancer Research Team
Contact Phone:
571-472-0629
Contact Email:
breastcancerresearch@inova.org
Additional information can be found at
https://clinicaltrials.gov/ct2/show/NCT02364557