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Breast CancerPhase 2NCT00246090

A Phase II Study of E7389 in Patients With Breast Cancer, Previously Treated With Anthracycline, Taxane and Capecitabine

A Phase 2 study testing E7389 in people with Breast Cancer, run by Eisai Inc. at 65 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine as prior therapy, and who are refractory to the last prior therapy for their disease. 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?
E7389
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
65 sitesin 2 countries
Study dates
Oct 2005to Sep 2007
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

  • Female patients with histologically or cytologically confirmed carcinoma of the breast. Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.
  • Patients with locally advanced or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least one of which was administered for treatment of locally advanced or metastatic disease.
  • Prior therapy must be documented by the following criteria prior to entry onto study:
  • Regimens must have included an anthracycline (eg, doxorubicin, epirubicin), a taxane (eg, paclitaxel, docetaxel) and capecitabine in any combination or order.
  • One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy.
  • Patients with human epidermal growth factor receptor 2 (HER2/neu) over-expressing tumors must additionally have been treated with trastuzumab.
Show all 24Show fewer
  • Patients with estrogen receptor-expressing tumors may have additionally been treated with estrogen-specific therapy.
  • Prior hormonal therapy, biological therapy, (eg, trastuzumab, bevacizumab), or immunotherapy, is not to be counted as one of the 2 to 5 prior chemotherapy regimens allowed. However, hormonal therapy must be discontinued one week before administration of E7389, and biological therapy must be discontinued two weeks before E7389 administration.
  • Patients who are being treated with bisphosphonates when they enter the study are allowed to continue the medication as long as the dosing does not change. In case a change in dosing is deemed necessary, the case needs to be discussed with the Sponsor.
  • Progression on or within six months of the last regimen for advanced disease, documented by the following:
  • The dates of treatment, doses, outcome of therapy and the reason for discontinuation of prior anthracycline, taxane, capecitabine, and trastuzumab therapy must be provided.
  • Prior to entry onto the study, information ensuring that the last therapy fulfills eligibility criteria is required, which includes progression while receiving this last prior chemotherapy regimen, or within six months of receiving that therapy.
  • Chemotherapy medication administration sheets or other official medical/hospital records indicating type and dates of chemotherapy must be available for inspection, and one of the following as a reason for discontinuation of medication is required: radiographic evidence of progression, or doctor's office or hospitalization notes documenting radiologic progression, clinically documented increase in tumor burden, and/or increase in tumor-specific markers.
  • Patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter [LD] by spiral computer tomography [CT] scan), or at least 20 mm by standard techniques. If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a biopsy or aspiration with cytological or histological confirmation of the diagnosis of breast carcinoma is required.
  • Resolution of all chemotherapy or radiation-related toxicities to less than Grade 2 severity, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
  • Age >= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Life expectancy of ≥ 3 months.
  • Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance ≥ 40 mL/minute (min) per the Cockcroft and Gault formula.
  • Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥1.5 x 10^9/L hemoglobin ≥ 10.0 g/dL (acceptable if it is corrected by therapeutic intervention or transfusional support), and platelet count ≥ 100 x 10^9/L.
  • Adequate liver function as evidenced by bilirubin ≤ 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) ≤ 3 times the upper limits of normal (ULN) (in the case of liver metastases ≤ 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.
  • Willing and able to complete the European Organization for Research on the Treatment of Cancer (EORTC) quality of life assessment, Analgesic Diary, and Pain Visual Analog Scale (VAS).
  • Willing and able to comply with the study protocol for the duration of the study.
  • Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

Who cannot join

  • Patients must not have received chemotherapy, radiation, or biologic therapy within two weeks, hormonal therapy within one week, or trastuzumab within three weeks, before E7389 treatment start.
  • Patients must not have received radiation therapy encompassing > 30% of marrow (a lesion that has been irradiated cannot be used as a target lesion, unless it has progressed after the irradiation).
  • Patients must not have pre-existing neuropathy > Grade 2.
  • Patients must not have participated in a prior E7389 clinical trial.

Trial locations and contacts

65 sites in 2 countries.

65 sites in 2 countries

United States60 sites

  • New York Oncology Hematology, P.C

    Albany, New York, 12208

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Peachtree Hematology And Oncology Consultants

    Atlanta, Georgia, 30309

  • Texas Oncology, P.A. Bedford

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35205

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35213

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29403

  • University of Chicago

    Chicago, Illinois, 60637

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Center For Oncology Research and Treatment, PA

    Dallas, Texas, 75230

  • Texas Oncology PA

    Dallas, Texas, 75231

  • Sammons Cancer Center-Dallas

    Dallas, Texas, 75246

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Rocky Mountain Cancer Center-Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Center-Rose

    Denver, Colorado, 80220

  • North Shore Hematology Oncology Associates

    East Setakuet, New York, 11733

  • El Paso Cancer Treatment Center West

    El Paso, Texas, 79902

  • El Paso Cancer Treatment Center

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Fairfax Northern VA Hematology Oncology PC

    Fairfax, Virginia, 22031

  • Frederick Memorial Hospital, Regional Cancer Therapy Center

    Frederick, Maryland, 21701

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Mercy Cancer Center

    Hot Springs, Arkansas, 71913

  • Texas Oncology PA

    Houston, Texas, 77024

  • Baylor College of Medicine, Breast Cancer Clinic

    Houston, Texas, 77030

  • Northwestern Carolina Oncology And Hematology, PA

    Hudson, North Carolina, 28602

  • Huntington Medical Group, PC

    Huntington Station, New York, 11746

  • Central Indiana Cancer Center

    Indianapolis, Indiana, 46227

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Wilshire Oncology Medical Group, Inc.

    La Verne, California, 91750

  • Arkansas Cancer Research Center

    Little Rock, Arkansas, 72205

  • Rocky Mountain Cancer Center

    Littleton, Colorado, 80210

  • 'Signal Point Hematology/Oncology, Inc.

    Middletown, Ohio, 45042

  • Park Nicollet Institute

    Minneapolis, Minnesota, 55416

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Monroe Medical Center

    Munster, Indiana, 46321

  • Weill Cornell Breast Cancer Center

    New York, New York, 10021

  • Cancer Care and Hematology Specialist of Chicagoland

    Niles, Illinois, 60714

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73112

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73120

  • North Texas Regional Cancer Center

    Plano, Texas, 75075

  • Cancer Research Network

    Plantation, Florida, 33324

  • Hematology-Oncology Associates

    Port Saint Lucie, Florida, 34952

  • Northwest Cancer Specialist Rose Qtr

    Portland, Oregon, 97225

  • Kaiser Permanente, Central Interstate Clinic, Hematology Oncology

    Portland, Oregon, 97227

  • Northwest Cancer Specialist Hoyt

    Portland, Oregon, 97227

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina, 27511

  • Oncology and Hematology Associates

    Salem, Virginia, 24153

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Cancer Care Northwest

    Spokane, Washington, 99218

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Dr. Elizabeth Tan-Chiu, PA

    Tamarac, Florida, 33321

  • Medical University of Ohio

    Toledo, Ohio, 43614

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialist

    Vancouver, Washington, 98684

  • Valley Oncology PA

    Weslaco, Texas, 78596

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

Other trials in United States

Canada5 sites

  • Hamilton Health Sciences Juravinski Cancer Centre

    Hamilton, Ontario, L8VSC2

  • Centre Hospitaliere Universitaire de Montreal

    Montreal, Quebec, H2L4MI

  • McGill University, Dept. of Oncology, Clinical Research Program

    Montreal, Quebec, H2W1S6

  • NW Ontario Regional Cancer Centre

    Thunder Bay, Ontario, P7B6V4

  • Toronto East General Hospital

    Toronto, Ontario, M4C3E7

Other trials in Canada

About this study

Official title: A Phase II Open Label Single-Arm Study of E7389 in Patients With Locally Advanced or Metastatic Breast Cancer, Previously Treated With Anthracycline, Taxane, and Capecitabine Therapy, Refractory to the Last Prior Therapy for Their Disease

The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine as prior therapy, and who are refractory to the last prior therapy for their disease.

Conditions
Breast Cancer
Being tested
E7389
Medical subject headings
Breast Neoplasms

What participants receive

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

  • E7389Drug

    E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.

Study groups in NCT00246090
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: E7389

What is being measured

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

  1. Objective Response Rate

    Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).

    Measured: Every two cycles

Secondary outcomes (1)

  1. Duration of Response

    Complete response (CR) is defined as the disappearance of all lesions. Partial response (PR) is defined as 30% decrease in lesion diameter.

    Measured: From first documented complete or partial response until disease progression or death

Timeline

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

  1. First posted31 Oct 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionSep 2007
  4. Study completionSep 2007

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00246090
Sponsor's protocol ID
E7389-G000-211
Other IDs
2005-003656-35, 2005
Status last verified
Apr 2012
First submitted
27 Oct 2005
Last updated
14 Jul 2014

Publications

  • Muss H, Cortes J, Vahdat LT, Cardoso F, Twelves C, Wanders J, Dutcus CE, Yang J, Seegobin S, O'Shaughnessy J. Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer. Oncologist. 2014 Apr;19(4):318-27. doi: 10.1634/theoncologist.2013-0282. Epub 2014 Mar 28.

    PubMed 24682463

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E7389 in people with Breast Cancer, run by Eisai Inc. at 65 sites in 2 countries.

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 24 inclusion and 4 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Canada. 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 15 May 2012). 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?

Objective Response Rate (time frame: Every two cycles). 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 NCT00246090, which also lists 1 linked publication.

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 14 Jul 2014.

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