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A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Academic and Community Cancer Research United
Sponsor:
Information provided by (Responsible Party):
Academic and Community Cancer Research United
ClinicalTrials.gov Identifier:
NCT02037529
First received: January 14, 2014
Last updated: January 26, 2016
Last verified: January 2016
  Purpose
This is a two arm Phase III trial in first and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression will be followed with repeat imaging studies every 12 weeks. All subjects will be followed until death, withdrawal of consent, or study termination.

Condition Intervention Phase
Metastatic Breast Cancer
Locally Recurrent Breast Cancer
Drug: Eribulin
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Academic and Community Cancer Research United:

Primary Outcome Measures:
  • Overall Survival (OS) of subjects from Baseline taking eribulin mesylate vs. subjects taking paclitaxel [ Time Frame: Baseline until death, or up to 4 years ] [ Designated as safety issue: Yes ]
    The time from randomization to death due to any cause; subjects who are lost to follow-up and subjects who are alive at the date of data cut-off will be censored at the date the subject was last known alive.


Secondary Outcome Measures:
  • Objective tumor response as defined by RECIST 1.1 [ Time Frame: Baseline until death, or up to 4 years ] [ Designated as safety issue: No ]
  • Duration of tumor response [ Time Frame: Baseline until death, or up to 4 years ] [ Designated as safety issue: No ]
  • Time-to-treatment-failure of eribulin mesylate [ Time Frame: Baseline until death, or up to 4 years ] [ Designated as safety issue: No ]
  • Treatment-related toxicity of eribulin mesylate [ Time Frame: Baseline until death, or up to 4 years ] [ Designated as safety issue: No ]
    To assess the toxicities in patients receiving eribulin versus standard weekly paclitaxel.

  • Progression-Free Survival (PFS) defined as the time from randomization to progression (under RECIST 1.1 criteria) or death due to any cause, whichever occurs first [ Time Frame: Baseline until death, or up to 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 910
Study Start Date: March 2014
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Eribulin on Days 1 and 8 of each cycle (cycle length: 21 days)
Drug: Eribulin
Active Comparator: B
Paclitaxel on Days 1, 8, and 15 of each cycle (cycle length: 28 days)
Drug: Paclitaxel

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic confirmation of invasive adenocarcinoma originating in the breast.
  2. Stage IV disease or Stage IIIC disease (using the 7th edition AJCC criteria) not amenable to local therapy.
  3. Radiographically measurable disease as per RECIST guidelines (version 1.1).
  4. Radiographic evidence of disease progression.
  5. Documentation of HER2 negative breast cancer at the time of protocol registration.
  6. Known hormone receptor status at the time of protocol registration.
  7. Prior systemic therapy as per the following criteria:

    1. Patients must demonstrate resolution of all prior chemotherapy or radiation-related toxicities to grade less than or equal to 1, including peripheral neuropathy, with the exception of alopecia (any grade permissible).
    2. No more than one prior chemotherapy regimen for advanced or metastatic breast cancer is allowed. Prior chemotherapy for metastatic disease must have been completed greater than or equal to 14 days prior to randomization.
    3. Prior treatment may include a taxane in the adjuvant or neoadjuvant setting, provided that the interval between the completion of adjuvant therapy and disease recurrence is greater than 12 months.
    4. Any number of prior hormonal therapies is allowed.
    5. Any number of biologic therapies (e.g., bevacizumab) or immunotherapies is allowed in the absence of co-administered chemotherapy and must have been completed greater than or equal to 28 days prior to randomization.
    6. Prior treatment with an investigational agent is allowed but must have been completed greater than or equal to 28 days prior to randomization.
  8. Prior local therapy as per the following criteria:

    1. Minor surgical procedures must be completed greater than or equal to 7 days prior to randomization with documentation of adequate recovery from associated complications to grade less than or equal to 1.
    2. Major surgical procedures and open biopsies must be completed greater than or equal to 28 days prior to randomization with documentation of adequate recovery from associated complications to grade less than or equal to 1.
    3. Prior radiotherapy must be completed greater than or equal to 14 days prior to randomization with documentation of adequate recovery from associated toxicities to grade less than or equal to 1.
  9. Concurrent supportive therapy as per the following criteria:

    1. Treatment with bisphosphonates or denosumab is allowed and recommended per the standard of care.
    2. Therapeutic anticoagulation is allowed for patients on a stable dose of warfarin or low molecular weight heparin.
  10. ECOG performance status of 0, 1, or 2.
  11. Life expectancy of greater than 12 weeks.
  12. History of brain metastases as per the following criteria:

    1. Patients with a history of resected brain metastases are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including less than or equal to 28 days of study registration.
    2. Patients who receive stereotactic radiosurgery or whole brain radiation for brain metastases are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including less than or equal to 28 days of study registration.
  13. Adequate organ function per blood work obtained less than 7 days prior to registration.

    1. Absolute neutrophil count greater than or equal to 1500/uL.
    2. Platelet count greater than or equal to 100,000/uL.
    3. Hemoglobin greater than or equal to 9 g/dL.
    4. Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.
    5. SGOT (AST) and SGPT (ALT) less than or equal to 3 x ULN except in the case of liver metastases, where less than or equal to 5 x ULN is allowed.
    6. Creatinine less than or equal to 2.0 mg/dL or creatinine clearance greater than 50 mL/min.
    7. QTc interval less than or equal to 500 msec on the baseline electrocardiogram.
    8. Negative pregnancy test done less than or equal to 72 hours prior to registration for women of childbearing potential only.
  14. Ability to complete questionnaire(s) independently or with assistance.
  15. Willingness to provide blood and tissue samples for correlative research purposes.
  16. Ability to comprehend and respond to questions using a telephone keypad.

Exclusion Criteria:

  1. Prior malignancy, other than carcinoma in situ of the cervix and non-melanoma skin cancers, unless the prior malignancy was diagnosed and definitively treated greater than or equal to 5 years previously, there is no subsequent evidence of recurrence, and the patient is considered by a physician to be at less than 30% risk of relapse.
  2. Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:

    1. Pregnant women
    2. Nursing women
    3. Men or women of childbearing potential who are unwilling to employ adequate contraception
  3. Presence of a serious nonhealing wound, ulcer, or bone fracture.
  4. History of CTCAE grade greater than or equal to 3 hypersensitivity to paclitaxel or Cremophor EL.
  5. Pre-existing peripheral neuropathy grade greater than or equal to 2 at registration.
  6. Significant cardiovascular impairment (e.g., New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia).
  7. Subjects with known positive HIV status.
  8. History of stroke or transient ischemic attack less than or equal to 6 months prior to registration.
  9. History of uncontrolled seizures.
  10. Severe or uncontrolled intercurrent illness/infection.
  11. Concurrent administration of any other investigational agent considered to have potential efficacy in the treatment of breast cancer.
  12. Prior exposure to eribulin mesylate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037529

Contacts
Contact: Clinical Trials Referrals Office 855-776-0015

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Office    855-776-0015      
Principal Investigator: Donald W Northfelt, MD         
United States, Delaware
Christiana Care Health Services, Helen F. Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Kathleen Combs, RN, OCN, CCRP    3026234450    kcombs@christianacare.org   
Principal Investigator: Michael J Guarino, MD         
United States, District of Columbia
MedStar Georgetown University Hospital Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Julie Castle, RN    202-687-2209    bickmorj@georgetown.edu   
Contact: Nellie Novielli, RN    202-784-3923    noviella@georgetown.edu   
Principal Investigator: Claudine Isaacs, MD         
Washington Cancer Institute at MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Bianca Green, RN    202-877-8239    Bianca.z.green@medstar.net   
Principal Investigator: Avani S Mohapatra, MD         
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Referral Office    507-538-7623      
Principal Investigator: Alvaro Moreno-Aspitia, MD         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Alisha Williams, RN    312-413-2746    alishaw@uic.edu   
Principal Investigator: Oana C Danciu, MD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jean Gibson, RN    773-834-2167    jgibson@medicine.bsd.uchicago.edu   
Principal Investigator: Gini Fleming, MD         
Illinois CancerCare, P.C. Recruiting
Peoria, Illinois, United States, 61615
Contact: Ashton Hitchcock, BS    309-243-3611    ahitchcock@illinoiscancercare.com   
Principal Investigator: Sachdev P Thomas, MD         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Kendrith Rowland, MD    217-383-3010    Kendrith.Rowland@Carle.com   
Principal Investigator: Kendrith Rowland, MD         
United States, Iowa
Oncology Associates at Mercy Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Lynn Arens, CCRP    319-363-2690 ext 1      
Principal Investigator: Deborah Wilbur, MD         
Iowa Oncology Research Association Recruiting
Des Moines,, Iowa, United States, 50309
Contact: Katie Jensen, BS    515-244-7586    kjensen@iora.org   
Principal Investigator: Robert J Behrens, MD         
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Tom S Hoopingarner, R.N., BSN    712-252-9326    shoaresearch@shoaresearch.org   
Principal Investigator: Donald B Wender, M.D., Ph.D         
United States, Kansas
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Susan Stockton, RN, BSN, OCN    316-262-4467    susan.stockton@cancercenterofkansas.com   
Principal Investigator: Shaker R Dakhil, MC, FACP         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Alison McDaniel, RN, BSN, OCN    504-842-3683    amcdaniel@ochsner.org   
Principal Investigator: John Cole, MD         
United States, Maine
Harold Alfond Center for Cancer Care Recruiting
Augusta, Maine, United States, 04330
Contact: Kathy Malatesta, RN    207-626-4855    Kathy.malatesta@mainegeneral.org   
Principal Investigator: Thomas H Openshaw, MD         
United States, Michigan
Cancer Research Consortium of West Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Connie Szczepanek, RN BSN    616-391-1230    grcop-regulatory@grcop.org   
Principal Investigator: Gilbert Padula, MD         
United States, Minnesota
Essentia Health Duluth Clinic Recruiting
Duluth, Minnesota, United States, 55805
Contact: Diane Nelson, RN    218-786-3308      
Principal Investigator: Bret E B Friday, MD, PhD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referrals Office    855-776-0015      
Principal Investigator: Minetta C Liu, MD         
Coborn Cancer Center at the St. Cloud Hospital Recruiting
St. Cloud, Minnesota, United States, 56303
Contact: Stacy A Veches, BSN, RN    320-229-5199 ext 70826    vechess@centracare.com   
Principal Investigator: Donald J Jurgens, MD         
United States, Missouri
Ellis Fischel Cancer Center - University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65212
Contact: Angela Waller, RN    573-884-0053    wallera@health.missouri.edu   
Principal Investigator: Akm Hossain, MD         
Heartland Regional Medical Center - The Cancer Center Recruiting
St Joseph, Missouri, United States, 64507
Contact: Mary A Grant, RN CRC    816-271-1301    maryann.grant@mymlc.com   
Principal Investigator: Rony M Abou Jawde, MD         
Washington University School of Medicine Recruiting
St Louis, Missouri, United States, 63110
Contact: Jill Anderson    314-747-5209    JANDERS1@DOM.wustl.edu   
Principal Investigator: Michael Naughton, MD         
Missouri Baptist Medical Center Recruiting
St. Louis, Missouri, United States, 63131
Contact: Henry Robinson, CCRP    314-996-5865      
Principal Investigator: Alan P Lyss, MD         
United States, Nebraska
Missouri Valley Cancer Consortium Recruiting
Omaha, Nebraska, United States, 68106
Contact: Mary B Wilwerding, RN    402-991-8070    mwilwerding@mvcc.cc   
Principal Investigator: Gamini Soori, MD         
The University of Nebraska Medical Center (UNMC)/Fred & Pamela Buffett Cancer Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Mary Mary Mailliard, RN, OCN    402-559-5582    mjmailli@unmc.edu   
Principal Investigator: Elizabeth C Reed, MD         
United States, New Hampshire
New Hampshire Oncology Hematology Associates Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Clinical Research Dept.    603-622-6484      
Principal Investigator: DOUGLAS J WECKSTEIN, MD         
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Peter A Kaufman, MD    603-653-6181    Peter.A.Kaufman@hitchcock.org   
Principal Investigator: Peter A Kaufman, MD         
United States, New York
Hematology Oncology Associates of Central New York, P.C. Recruiting
East Syracuse, New York, United States, 13057
Contact: Kelly Cohn, RN    315-472-7504    kcohn@hoacny.com   
Principal Investigator: Jeffrey J Kirshner, MD         
United States, North Carolina
Mission Health Cancer Center Recruiting
Asheboro, North Carolina, United States, 28801
Contact: Mary E Hartwick, RN    828-213-4134    Mary.hartwick@msj.org   
Principal Investigator: Christopher H Chay, MD         
Cone Health Cancer Center at Alamance Regional Recruiting
Burlington, North Carolina, United States, 27215
Contact: Kaye Shoffner, BSN, MHA    336-538-7197    shofkare@armc.com   
Principal Investigator: Timothy Finnegan, MD         
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Michele R Vickers, LPN    984-974-8249    Michele_vickers@med.unc.edu   
Principal Investigator: Trevor A Jolly, MBBS         
Southeastern Medical Oncology Center Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: Elaine T Cooke, CCRP    919-587-9088    ecooke@cancersmoc.com   
Principal Investigator: James N Atkins, MD         
FirstHealth Outpatient Cancer Center Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Lori DeSpain, RN-C    910-715-2200    LDeSpain@firsthealth.org   
Principal Investigator: Charles S Kuzma, MD         
Novant Health Oncology Specialists Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Elizabeth C White, CCRP    336-718-8461    ecwhite@novanthealth.org   
Principal Investigator: Judith O Hopkins, MD         
United States, Oklahoma
Cancer Centers of Southwest Oklahoma Recruiting
Lawton, Oklahoma, United States, 73505
Contact: Susie Mccoy, RN BSN OCN    580-536-2121    susie.mccoy@ccswok.org   
Principal Investigator: Nadim F Nimeh, MD         
United States, Oregon
Providence Cancer Center Recruiting
Portland, Oregon, United States, 97213
Contact: Nikki Moxon, RN    503-215-2619    Nikki.moxon@providence.org   
Principal Investigator: Alison Conlin, MD         
United States, Rhode Island
Women and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Emma Locke, BS    401-274-1122 ext 48181    elocke@wihri.org   
Principal Investigator: William M Sikov, M.D.         
United States, South Dakota
Rapid City Regional Hospital/Regional Cancer Care Institute Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Angie Dunbar, N    605-755-2370    adunbar@regionalhealth.com   
Principal Investigator: Mark T Schroeder, MD         
United States, West Virginia
Edwards Comprehensive Cancer Center Recruiting
Huntington, West Virginia, United States, 25701
Contact: Keshia Bowen, RN    304-399-6521    Keshia.bowen@chhi.org   
Principal Investigator: Maria T Tirona, MD         
United States, Wisconsin
St. Mary's Hospital Medical Center/ Green Bay Oncology, Ltd. Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Jodi A Koch, RN BSN OCN CCRP    920-884-3491    Jodi.Koch@hshs.org   
Principal Investigator: Anthony J Jaslowski, MD         
Sponsors and Collaborators
Academic and Community Cancer Research United
Investigators
Study Chair: Liu C Minetta, M.D. Academic and Community Cancer Research United
  More Information

Responsible Party: Academic and Community Cancer Research United
ClinicalTrials.gov Identifier: NCT02037529     History of Changes
Other Study ID Numbers: E7389-A001-303  RU011201I 
Study First Received: January 14, 2014
Last Updated: January 26, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Academic and Community Cancer Research United:
Breast Cancer
Metastatic
Locally Recurrent

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016