RWF_12-017

Phase I/II Study of Stereotactic Body Radiation Therapy to Metastatic Lesions in the Liver or Lung in Combination with Monoclonal Antibody to OX40 in Patients with Progressive Metastatic Breast Cancer After Systemic Therapy.

This study will test the investigational antibody, anti-OX40, in combination with stereotactic body radiation in breast cancer patients that have liver or lung metastases and have received systemic therapy and have progressive disease. The investigators hypothesize that SBRT directed at metastatic breast cancer lesions will result in a systemic anti-tumor immune system response. This amplified and directed immune response could result in anti-tumor responses.

Key Eligibility:

* Histologically confirmed breast cancer with clinical evidence of stage 4 disease

* Measurable disease and at least one lesion in either liver or lung that is amenable to stereotactic body radiation

* One site of disease that will not receive radiation

* Patients with hormone receptor positive breast cancer must have received prior anti-hormonal therapy for metastatic disease and have progressed and patients with hormone receptor negative breast cancer must have received at least one prior chemotherapy regimen and progressed.

* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
Phase I/II
NCT01862900
Oncology
Breast
Marka Crittenden, M.D., Ph.D.
Earle A Chiles Research Institute (EACRI)
Nikki Moxon
  • Oncology and Hematology Care Eastside
  • Providence Portland Medical Center