Fresolimumab and Radiotherapy in Metastatic Breast Cancer

Exclusion Criteria

• •Second malignancy - unless following curative intent therapy, has been disease free for ≥2 years with probability of recurrence \<5%. Curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are allowed.
• •Concurrent cancer therapy.
• •Uncontrolled central nervous system (CNS) metastases, meningeal carcinomatosis, malignant seizures, or disease that causes or threatens neurologic compromise (e.g. unstable vertebral metastases).
• •History of ascites or pleural effusions, unless successfully treated.
• •Organ transplant, including allogeneic bone marrow transplant.
• •Immunosuppressive therapy including:
• •* Systemic corticosteroid therapy, including replacement therapy for hypoadrenalism. Inhaled or topical corticosteroids are allowed (if therapy is \<5 days and is limited to systemic steroids as antiemetics);
• •* Cyclosporine A, tacrolimus, or sirolimus.
• •Investigational agents within 4 weeks prior to study enrollment (≥6 weeks if treatment was long-acting agent such as monoclonal antibody).
• •Significant or uncontrolled medical illness, e.g. congestive heart failure (CHF), myocardial infarction, symptomatic coronary artery disease, significant ventricular arrhythmias within the last 6 months, or significant pulmonary dysfunction. Patients with remote history of asthma or active mild asthma may participate.
• •Active infection, including unexplained fever (\>38.5°C).
• •Systemic autoimmune disease (e.g. systemic lupus erythematosus, active rheumatoid arthritis).
• •Known allergy to any component of GC1008.
• •Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding, or anti-coagulation therapy (including anti platelet agents i.e. aspirin, clopidogrel, ticlopidine, dipyridamole, other agents inducing long-acting platelet dysfunction). Patients with history of deep venous thrombosis are allowed if treated, completely resolved, and no treatment for \>4months.
• •Calcium \>11.0mg/dL (2.75mmol/L) unresponsive or uncontrolled in response to standard therapy (e.g. bisphosphonates).
• •Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems, including, but not limited to:
• •* Other serious non-malignancy-associated conditions that may be expected to limit life expectancy or significantly increase the risk of SAEs;
• •* Conditions, psychiatric, substance abuse, or other, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study;
• •Pregnant or nursing women.