A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast Cancer

Exclusion Criteria

• •Have a concurrent active other malignancy other than adequately treated non-melanomatous skin cancer or other noninvasive or in situ neoplasms
• •Are currently enrolled in, or recently discontinued from, a clinical trial involving an investigational product, or concurrently enrolled in any other type of medical research judged not to be medically compatible with the study
• •Have received investigational therapy within 3 weeks prior to randomization
• •Have received prior ramucirumab or eribulin
• •Have a known sensitivity to agents of similar biologic composition as ramucirumab, halichondrin B and/or halichondrin B chemical derivative
• •Have received bevacizumab within 6 weeks prior to randomization
• •Have uncontrolled or poorly controlled hypertension
• •Have congenital prolonged QTc syndrome (or have a family history) or prolongation of QTc at baseline
• •Have a history of additional risk factors for torsades de pointes within the last year prior to randomization
• •Have an implantable pacemaker or automatic implantable cardioverter defibrillator
• •Have bradycardia
• •Have an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention within 6 months prior to randomization
• •Have a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
• •Have experienced a Grade 3 or greater bleeding event within 3 months prior to randomization
• •Have experienced any Grade 3 or greater arterial thromboembolic events within 6 months prior to randomization, or venous thromboembolic event within 3 months prior to randomization
• •Have undergone major surgery within 4 weeks prior to randomization or subcutaneous venous access device placement within 7 days prior to randomization
• •Have a planned major surgery to be performed during the course of the trial
• •Have uncontrolled metabolic conditions
• •Have an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
• •Have known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
• •Have pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment including the use of oxygen
• •Have received a prior allogeneic organ or tissue transplantation
• •Have had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to randomization
• •Have known leptomeningeal metastases
• •Have cirrhosis (Child-Pugh Level B or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites