Click here to close now.


News Feed Item

Eisai Announces Initiation of a Phase 3 Trial of Eribulin Mesylate Injection Versus Weekly Paclitaxel in First and Second Lines of Metastatic Breast Cancer

Patient Recruitment Now Underway at Treatment Centers Across the United States

WOODCLIFF LAKE, N.J., Feb. 27, 2014 /PRNewswire/ -- Eisai Inc. today announced the start of a large, randomized Phase 3 trial to compare the efficacy, safety and tolerability of eribulin mesylate to standard weekly paclitaxel as a first- or second- line treatment for HER2-negative locally recurrent or metastatic breast cancer (MBC). Recruitment is currently active for this multicenter study, conducted in partnership with the Academic and Community Cancer Research United (ACCRU) group, and aims to enroll approximately 910 patients across the U.S. The primary endpoint is overall survival.

Eisai logo.

This research study involves an investigational use of eribulin mesylate. The efficacy and safety of eribulin mesylate in first- and second-line MBC have not been established and this release is not intended to convey conclusions of efficacy and safety.

"As a human healthcare company, Eisai is committed to further exploring new treatments for metastatic breast cancer patients," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai.

About The Study
This study is for HER2-negative breast cancer patients who have received no more than one prior chemotherapy regimen once their breast cancer has spread. Eligible patients will be randomly selected with equal allocation (1:1) to receive treatment for their cancer with either eribulin mesylate or standard weekly paclitaxel, within strata defined by prior adjuvant taxanes, hormone receptor status (ER/PgR), and line of therapy.

The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival and objective tumor response rate. Safety and tolerability of the treatment groups will also be continuously monitored.

To learn more about this clinical trial, please visit

About Metastatic Breast Cancer
Metastatic breast cancer (MBC) is the form of the disease that refers to the most advanced stage, in which cancer cells break away from the tumor in the breast, spread to other parts of the body and continue growing. In 2013, an estimated 234,580 women will be diagnosed with breast cancer in the U.S. Approximately 30 percent of patients having an initial diagnosis of early-stage breast cancer will go on to develop recurrent, advanced or MBC.

About Eribulin Mesylate Injection
Eribulin mesylate injection (available as Halaven®) is currently indicated for patients with breast cancer who have received at least two other types of medicines for their breast cancer once it has spread. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer. Eribulin is a non-taxane, microtubule dynamics inhibitor that is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai.

Important Safety Information

  • Decreased White Blood Cells (Neutropenia)
    • Doctors should do blood tests to monitor patients' blood cells before they receive each dose of HALAVEN, and should monitor them more often if they develop lower white blood cells.
    • If patients develop severe neutropenia lasting longer than 7 days or neutropenia with a fever, their next dose of HALAVEN should be delayed and reduced. Severe neutropenia occurred in 57% of patients who received HALAVEN and lasted more than 1 week in 12% of patients.
    • Neutropenia with a fever occurred in 5% of patients; 2 patients died from complications of neutropenia with a fever. 
    • Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Patients should call their healthcare providers immediately if they have any of the following symptoms; fever (temperature above 100.5 ۫ F), chills, coughing, burning or pain when they urinate.
  • Nerve Disorders (Peripheral Neuropathy)
    • HALAVEN can cause numbness, tingling, or burning in a patient's hands and feet (peripheral neuropathy). Patients should be monitored closely for signs of neuropathy. If they develop severe neuropathy, treatment with HALAVEN should be delayed until the neuropathy improves and the next dose of HALAVEN should be reduced.
    • Severe peripheral neuropathy occurred in 8% of patients who received HALAVEN. Neuropathy lasting more than one year occurred in 5% of patients. 22% of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days. 
    • Peripheral neuropathy was the most common side effect that caused patients to stop receiving HALAVEN.
  • Pregnancy and Nursing
    • HALAVEN may harm a patient's unborn baby. Patients must avoid becoming pregnant while they are receiving HALAVEN. They should tell their healthcare providers right away if they become pregnant or think they are pregnant while they are receiving HALAVEN.
    • Patients and their healthcare providers should decide if they will receive HALAVEN or breastfeed. They should not do both.
  • Heartbeat Changes
    • HALAVEN can cause changes in a patient's heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death.
    • Healthcare providers will decide if patients need heart monitoring (electrocardiogram or ECG), or blood tests during their treatment with HALAVEN to watch for this problem. 
  • Liver and Kidney Problems
    • In patients with mild or moderate liver problems, and/or moderate kidney problems, a lower starting dose of HALAVEN is recommended.
  • Most Common Side Effects
    • The most common side effects reported in >25% of patients receiving HALAVEN were low white blood cells (82%), low red blood cells (58%), weakness/tiredness (54%), hair loss (45%), numbness, tingling or burning in your hands and feet (35%), nausea (35%), and constipation (25%).
    • The most common serious side effects reported in patients receiving HALAVEN were neutropenia with or without a fever (4% and 2%, respectively).

Please see the HALAVEN full prescribing information.

About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

The Academic and Community Cancer Research United (ACCRU) is a clinical research group whose operations are based at the Mayo Clinic Cancer Center in Rochester, Minn. ACCRU includes a network of more than 65 academic and community-based cancer treatment clinics and hospitals in the United States and Canada. ACCRU, formerly Mayo Clinic Cancer Research Consortium (MCCRC), was established in 2004 to conduct clinical trials to improve cancer care.

HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.

Media Inquiries

Investor Inquiries

Laurie Ostroff-Landau

Alex Scott

Eisai Inc.

Eisai Inc.



Logo -

SOURCE Eisai Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Sam McIntyre, Partner Enablement Specialist at eFolder, presented how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He also demonstrated how easy it is to search and restore cloud application data using Cloudfinder.
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and t...
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
As organizations shift towards IT-as-a-service models, the need for managing & protecting data residing across physical, virtual, and now cloud environments grows with it. CommVault can ensure protection & E-Discovery of your data - whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise.
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Continuous processes around the development and deployment of applications are both impacted by -- and a benefit to -- the Internet of Things trend. To help better understand the relationship between DevOps and a plethora of new end-devices and data please welcome Gary Gruver, consultant, author and a former IT executive who has led many large-scale IT transformation projects, and John Jeremiah, Technology Evangelist at Hewlett Packard Enterprise (HPE), on Twitter at @j_jeremiah. The discussion...
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound...
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem"...
In today's enterprise, digital transformation represents organizational change even more so than technology change, as customer preferences and behavior drive end-to-end transformation across lines of business as well as IT. To capitalize on the ubiquitous disruption driving this transformation, companies must be able to innovate at an increasingly rapid pace. Traditional approaches for driving innovation are now woefully inadequate for keeping up with the breadth of disruption and change facin...
PubNub has announced the release of BLOCKS, a set of customizable microservices that give developers a simple way to add code and deploy features for realtime apps.PubNub BLOCKS executes business logic directly on the data streaming through PubNub’s network without splitting it off to an intermediary server controlled by the customer. This revolutionary approach streamlines app development, reduces endpoint-to-endpoint latency, and allows apps to better leverage the enormous scalability of PubNu...
Container technology is shaping the future of DevOps and it’s also changing the way organizations think about application development. With the rise of mobile applications in the enterprise, businesses are abandoning year-long development cycles and embracing technologies that enable rapid development and continuous deployment of apps. In his session at DevOps Summit, Kurt Collins, Developer Evangelist at, examined how Docker has evolved into a highly effective tool for application del...
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Day 2 Keynote at 17th Cloud Expo, San...