Breast Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

141

Study ID:

NCT01427933

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 52 Locations for this study

See Locations Near You

ImClone Investigational Site
Birmingham Alabama, 35211, United States
ImClone Investigational Site
Gilroy California, 95020, United States
ImClone Investigational Site
Palm Springs California, 92262, United States
ImClone Investigational Site
Denver Colorado, 80220, United States
ImClone Investigational Site
Southington Connecticut, 06489, United States
ImClone Investigational Site
Fort Myers Florida, 33916, United States
ImClone Investigational Site
Jacksonville Florida, 32207, United States
ImClone Investigational Site
Orlando Florida, 32806, United States
ImClone Investigational Site
Plantation Florida, 33324, United States
ImClone Investigational Site
Port St Lucie Florida, 34952, United States
ImClone Investigational Site
St. Petersburg Florida, 33705, United States
ImClone Investigational Site
Tampa Florida, 33612, United States
ImClone Investigational Site
Albany Georgia, 31701, United States
ImClone Investigational Site
Lawrenceville Georgia, 30046, United States
ImClone Investigational Site
Park Ridge Illinois, 60068, United States
ImClone Investigational Site
Columbia Maryland, 21044, United States
ImClone Investigational Site
Rockville Maryland, 20850, United States
ImClone Investigational Site
Dearborn Michigan, 48126, United States
ImClone Investigational Site
Minneapolis Minnesota, 55404, United States
ImClone Investigational Site
St Louis Missouri, 63110, United States
ImClone Investigational Site
St. Joseph Missouri, 64507, United States
ImClone Investigational Site
Henderson Nevada, 89074, United States
ImClone Investigational Site
Morristown New Jersey, 07960, United States
ImClone Investigational Site
Bronx New York, 10469, United States
ImClone Investigational Site
Johnson City New York, 13790, United States
ImClone Investigational Site
Lake Success New York, 11042, United States
ImClone Investigational Site
Burlington North Carolina, 27215, United States
ImClone Investigational Site
Chapel Hill North Carolina, 27599, United States
ImClone Investigational Site
Dayton Ohio, 45429, United States
ImClone Investigational Site
Middletown Ohio, 45042, United States
ImClone Investigational Site
Toledo Ohio, 43623, United States
ImClone Investigational Site
Portland Oregon, 97213, United States
ImClone Investigational Site
Pittsburgh Pennsylvania, 15213, United States
ImClone Investigational Site
Charleston South Carolina, 29414, United States
ImClone Investigational Site
Greenville South Carolina, 29605, United States
ImClone Investigational Site
Chattanooga Tennessee, 37404, United States
ImClone Investigational Site
Nashville Tennessee, 37203, United States
ImClone Investigational Site
Arlington Texas, 76014, United States
ImClone Investigational Site
Bedford Texas, 76022, United States
ImClone Investigational Site
Dallas Texas, 75246, United States
ImClone Investigational Site
Fort Worth Texas, 76104, United States
ImClone Investigational Site
Houston Texas, 77024, United States
ImClone Investigational Site
Plano Texas, 75075, United States
ImClone Investigational Site
San Antonio Texas, 78217, United States
ImClone Investigational Site
The Woodlands Texas, 77380, United States
ImClone Investigational Site
Tyler Texas, 75702, United States
ImClone Investigational Site
Rutland Vermont, 05701, United States
ImClone Investigational Site
Fairfax Virginia, 22031, United States
ImClone Investigational Site
Norfolk Virginia, 23502, United States
ImClone Investigational Site
Richmond Virginia, 23230, United States
ImClone Investigational Site
Salem Virginia, 24153, United States
ImClone Investigational Site
Vancouver Washington, 98684, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

141

Study ID:

NCT01427933

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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