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

Purpose

 

• Have histologically or cytologically confirmed invasive breast cancer which at the time of study entry is either Stage III locally-recurrent disease not amenable to curative therapy or Stage IV disease (American Joint Committee on Cancer Staging Criteria for breast cancer)
• Have measurable or nonmeasurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
• Have received at least 2 but not more than 4 prior cytotoxic chemotherapy regimens in the advanced setting
• Have received prior treatment with both anthracyclines and taxanes, either in the metastatic, adjuvant or neoadjuvant setting
• Have received HER-2-directed treatment; or are not a candidate for HER-2-directed treatment if the patient has HER-2 positive disease
• Have completed any prior radiotherapy and/or hormonal therapy at least 1 week prior to randomization and have recovered from all clinically significant treatment-related toxicities
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Have left ventricular ejection fraction within normal limits
• Have discontinued all previous chemotherapy treatments for cancer at least 3 weeks prior to randomization and recovered from clinically significant toxic effects
• Have resolution to Grade less than or equal to 1 [by the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0] of all clinically significant toxicities of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy, which must have resolved to Grade less than or equal to 2
• Have adequate hematologic, hepatic, renal, and coagulation function
• Test negative for pregnancy
• Have a life expectancy of at least 3 months

• 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)
• Have a history of additional risk factors for Torsades des 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
• 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
• Have undergone major surgery within 4 weeks 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

 

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