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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

This is a study to compare the antitumor activity of ramucirumab (IMC-1121B) and eribulin together versus eribulin alone, in participants with locally recurrent or metastatic breast cancer.

Key facts

Study ID: NCT01427933
Run by: Eli Lilly and Company
People needed: 141
Starts: 2011-11-01
Expected to finish: 2014-06-01
Last updated by the study team: 2017-02-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Have histologically or cytologically confirmed invasive breast cancer which at the time of study entry is either locally recurrent disease not amenable to curative therapy or Stage IV disease (American Joint Committee on Cancer Staging Criteria for breast cancer)
Have measurable and/or nonmeasurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Have received at least 2 but not more than 4 prior cytotoxic chemotherapy regimens in the locally recurrent or metastatic setting
Have received prior treatment with both anthracyclines and taxanes, either in the metastatic, adjuvant or neoadjuvant setting
Have received Human Epidermal Growth Factor Receptor 2 (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

You may not qualify if…

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

Where it is running

ImClone Investigational Site — Gilroy, California, United States
ImClone Investigational Site — Palm Springs, California, United States
ImClone Investigational Site — Denver, Colorado, United States
ImClone Investigational Site — Southington, Connecticut, United States
ImClone Investigational Site — Fort Myers, Florida, United States
ImClone Investigational Site — Jacksonville, Florida, United States
ImClone Investigational Site — Orlando, Florida, United States
ImClone Investigational Site — Plantation, Florida, United States
ImClone Investigational Site — Port Saint Lucie, Florida, United States
ImClone Investigational Site — St. Petersburg, Florida, United States
ImClone Investigational Site — Tampa, Florida, United States
ImClone Investigational Site — Albany, Georgia, United States
ImClone Investigational Site — Lawrenceville, Georgia, United States
ImClone Investigational Site — Park Ridge, Illinois, United States
ImClone Investigational Site — Columbia, Maryland, United States
ImClone Investigational Site — Rockville, Maryland, United States
ImClone Investigational Site — Dearborn, Michigan, United States
ImClone Investigational Site — Minneapolis, Minnesota, United States
ImClone Investigational Site — Saint Joseph, Missouri, United States
ImClone Investigational Site — St Louis, Missouri, United States
ImClone Investigational Site — Henderson, Nevada, United States
ImClone Investigational Site — Morristown, New Jersey, United States
ImClone Investigational Site — Johnson City, New York, United States
ImClone Investigational Site — Lake Success, New York, United States
ImClone Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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