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Breast CancerPhase 2NCT01427933

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

A Phase 2 study testing Ramucirumab (IMC-1121B) and Eribulin in people with Breast Cancer, run by Eli Lilly and Company at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Ramucirumab (IMC-1121B) and Eribulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
52 sitesUnited States
Study dates
Nov 2011to Jun 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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 locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • ImClone Investigational Site

    Albany, Georgia, 31701

  • ImClone Investigational Site

    Arlington, Texas, 76014

  • ImClone Investigational Site

    Bedford, Texas, 76022

  • ImClone Investigational Site

    Birmingham, Alabama, 35211

  • ImClone Investigational Site

    Burlington, North Carolina, 27215

  • ImClone Investigational Site

    Chapel Hill, North Carolina, 27599

  • ImClone Investigational Site

    Charleston, South Carolina, 29414

  • ImClone Investigational Site

    Chattanooga, Tennessee, 37404

  • ImClone Investigational Site

    Columbia, Maryland, 21044

  • ImClone Investigational Site

    Dallas, Texas, 75246

  • ImClone Investigational Site

    Dayton, Ohio, 45429

  • ImClone Investigational Site

    Dearborn, Michigan, 48126

  • ImClone Investigational Site

    Denver, Colorado, 80220

  • ImClone Investigational Site

    Fairfax, Virginia, 22031

  • ImClone Investigational Site

    Fort Myers, Florida, 33916

  • ImClone Investigational Site

    Fort Worth, Texas, 76104

  • ImClone Investigational Site

    Gilroy, California, 95020

  • ImClone Investigational Site

    Greenville, South Carolina, 29605

  • ImClone Investigational Site

    Henderson, Nevada, 89074

  • ImClone Investigational Site

    Houston, Texas, 77024

  • ImClone Investigational Site

    Jacksonville, Florida, 32207

  • ImClone Investigational Site

    Johnson City, New York, 13790

  • ImClone Investigational Site

    Lake Success, New York, 11042

  • ImClone Investigational Site

    Lawrenceville, Georgia, 30046

  • ImClone Investigational Site

    Middletown, Ohio, 45042

  • ImClone Investigational Site

    Minneapolis, Minnesota, 55404

  • ImClone Investigational Site

    Morristown, New Jersey, 07960

  • ImClone Investigational Site

    Nashville, Tennessee, 37203

  • ImClone Investigational Site

    Norfolk, Virginia, 23502

  • ImClone Investigational Site

    Orlando, Florida, 32806

  • ImClone Investigational Site

    Palm Springs, California, 92262

  • ImClone Investigational Site

    Park Ridge, Illinois, 60068

  • ImClone Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • ImClone Investigational Site

    Plano, Texas, 75075

  • ImClone Investigational Site

    Plantation, Florida, 33324

  • ImClone Investigational Site

    Port Saint Lucie, Florida, 34952

  • ImClone Investigational Site

    Portland, Oregon, 97213

  • ImClone Investigational Site

    Richmond, Virginia, 23230

  • ImClone Investigational Site

    Rockville, Maryland, 20850

  • ImClone Investigational Site

    Rutland, Vermont, 05701

  • ImClone Investigational Site

    Saint Joseph, Missouri, 64507

  • ImClone Investigational Site

    Salem, Virginia, 24153

  • ImClone Investigational Site

    San Antonio, Texas, 78217

  • ImClone Investigational Site

    Southington, Connecticut, 06489

  • ImClone Investigational Site

    St Louis, Missouri, 63110

  • ImClone Investigational Site

    St. Petersburg, Florida, 33705

  • ImClone Investigational Site

    Tampa, Florida, 33612

  • ImClone Investigational Site

    The Bronx, New York, 10469

  • ImClone Investigational Site

    The Woodlands, Texas, 77380

  • ImClone Investigational Site

    Toledo, Ohio, 43623

  • ImClone Investigational Site

    Tyler, Texas, 75702

  • ImClone Investigational Site

    Vancouver, Washington, 98684

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Randomized, Phase 2 Study Evaluating the Efficacy and Safety of Ramucirumab (IMC-1121B) Drug Product in Combination With Eribulin Versus Eribulin Monotherapy in Unresectable, Locally-Recurrent or Metastatic Breast Cancer Patients Previously Treated With Anthracycline and Taxane Therapy

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.

Conditions
Breast Cancer
Being tested
Ramucirumab (IMC-1121B), Eribulin
Keywords
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ramucirumab (IMC-1121B)Biological

    Also called LY3009806

    Administered intravenously

  • EribulinDrug

    Administered intravenously

Study groups in NCT01427933
Study groupRoleWhat they receive
Ramucirumab and EribulinExperimentalRamucirumab 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
Receives: Biological: Ramucirumab (IMC-1121B); Drug: Eribulin
Eribulin MonotherapyActive comparatorEribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Receives: Drug: Eribulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.

    Measured: Start of treatment until documented disease progression or death from any cause up to 16.5 months

Secondary outcomes (5)

  1. Overall Survival (OS) Randomization to Date of Death From Any Cause

    Time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date, OS data were censored on the last date the participants were known to be alive prior to that cut-off date.

    Measured: Randomization to date of death from any cause up to 28.6 months

  2. Objective Response Rate (ORR) Percentage of Participants With Measurable Disease Achieving a Best Overall Response of Partial Response (PR) or Complete Response (CR)

    ORR was defined as the percentage of participants with measurable disease achieving a best overall response of PR or CR as defined by RECIST v.1.1. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in SOD of target lesions. Participants who did not have any post baseline tumor response assessments for any reason were considered non-responders and included in the denominator when calculating the response rate. ORR for each treatment arm calculated as: [(CR + PR in the treatment arm) divided by (total number of participants in the treatment arm)] x 100.

    Measured: Start of treatment until documented CR or PR up to 16.5 months

  3. Duration of Response (DOR) Time of Response to Progressive Disease

    DOR was measured from the time criteria were met for first objectively recorded CR or PR until first date criteria for PD was met or death. Response defined using RECIST v1.1 criteria. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of diameter (SOD) of target lesions. PD defined ≥20% increase in SOD of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.

    Measured: Time from Observed CR or PR to PD up to 12.1 months

  4. Change in Tumor Size (CTS)

    CTS was defines as the change from baseline measurement of target lesions to the post treatment measurement in participants with measurable disease. Change was assessed using radiographic imagining. Log ratio calculated as: log of (tumor size post baseline) divided by (tumor size at baseline). A negative result indicated a shrinking tumor.

    Measured: Baseline, 6 weeks

  5. Number of Participants With Anti-Ramucirumab Antibodies

    The number of participants who developed treatment-emergent antibody responses after baseline. The antibody test can produce positive results in participants without ramucirumab exposure. Treatment emergent anti-ramucirumab antibody positive was defined as: when baseline titer was greater than 0 and post baseline titer was equal to or greater than 4-fold the baseline titer or if the baseline titer was not detected and post baseline titer is equal to or greater than a value of 20.

    Measured: Day 1 of Cycle 1, Cycle 3, Cycle 5 and 30 days after last dose of study drug up to 17.7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionSep 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01427933
Sponsor's protocol ID
14392
Other IDs
I4T-IE-JVCD, CP12-1134
Status last verified
Dec 2016
First submitted
31 Aug 2011
Last updated
6 Feb 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramucirumab (IMC-1121B) and Eribulin in people with Breast Cancer, run by Eli Lilly and Company at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: Start of treatment until documented disease progression or death from any cause up to 16.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01427933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.

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