Stereotactic Body Radiation and Monoclonal Antibody to OX40 (MEDI6469) in Breast Cancer Patients With Metastatic Lesions — OX40 Breast  

Metastatic Breast Cancer Clinical Trial

Official title: Phase I/II Study of Stereotactic Body Radiation Therapy to Metastatic Lesions in the Liver or Lung in Combination With Monoclonal Antibody to OX40 (MEDI6469) in Patients With Progressive Metastatic Breast Cancer After Systemic Therapy.

Status Completed

Clinical Trial Summary

This study will test the investigational antibody, MEDI6469 (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.

Clinical Trial Description

Patients will receive one of three different doses of SBRT depending on which cohort they are in. The doses are:

Cohort 1: 15 Gy (central tumors 10 Gy); Cohort 2: 20 Gy (central tumors 15 Gy); Cohort 3: 20 Gy x 2 (central tumors 15 Gy x 2).

In addition, all patients will receive three doses of MEDI6469. MEDI6469 is administered at 0.4 mg/kg IV over 60 minutes using in-line filter on Days 1, 3, and 5. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Liver Metastases
• Lung Metastases
• Metastatic Breast Cancer
• Neoplasm Metastasis
• Neoplasms, Second Primary

• NCT number: NCT01862900
• Study type: Interventional
• Source: Providence Health & Services
• Status: Completed
• Phase: Phase 1
• Start date: April 27, 2012
• Completion date: August 15, 2018