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

Lilly

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Eribulin

Biological: Ramucirumab (IMC-1121B)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01427933

14392

I4T-IE-JVCD (Other Identifier)

CP12-1134 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

141 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

141 participants in 2 patient groups

Ramucirumab and Eribulin

Experimental group

Description:

Ramucirumab 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Treatment:

Biological: Ramucirumab (IMC-1121B)

Drug: Eribulin

Eribulin Monotherapy

Active Comparator group

Description:

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Treatment:

Drug: Eribulin