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Locally RecurrentPhase 2NCT01268150

A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer

A Phase 2 study testing Eribulin mesylate in people with Locally Recurrent and Metastatic Breast Cancer ( HER2 Negative), run by Eisai Inc. at 17 sites in United States.

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 assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Eribulin mesylate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
17 sitesUnited States
Study dates
Feb 2011to Aug 2013
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

  • Females age 18 years or older at the time of informed consent
  • Have histologically or cytologically proven adenocarcinoma of the breast
  • Subjects with locally recurrent or metastatic disease with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors
  • (RECIST) criteria v 1.1
  • Human epidermal growth factor receptor (HER2)-negative disease as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemical (IHC) staining.
  • Life expectancy of greater than 24 weeks
Show all 12Show fewer
  • Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2
  • At least 12 months since prior neoadjuvant or adjuvant chemotherapy
  • At least 2 weeks since prior radiotherapy or endocrine therapy, with complete recovery from the effects of these interventions
  • Adequate renal function
  • Adequate bone marrow function
  • Adequate liver function

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from participation in this study:
  • Prior chemotherapy, biologic therapy, or investigational therapy for locally recurrent or metastatic breast cancer
  • Subjects who have had a prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer
  • Prior exposure of greater than 360 mg/m2 doxorubicin or liposomal doxorubicin, greater than 120 mg/m2 mitoxantrone, greater than 90 mg/m2 idarubicin, or greater than720 mg/m2 epirubicin
  • Inflammatory breast cancer
  • Clinically significant cardiovascular impairment
Show all 10Show fewer
  • Subjects with known CNS disease are not eligible, except for those with treated brain metastasis.
  • Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring the use of oxygen
  • Currently pregnant or breast-feeding.
  • Subjects with pre-existing Grade 3 or 4 neuropathy. Any peripheral neuropathy must recover to Grade 2 before enrollment.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Augusta Oncology Associates

    Augusta, Georgia, 30901

  • Texas Oncology- Bedford

    Bedford, Texas, 76022

  • Hematology Oncology Centers of Northern Rockies

    Billings, Montana, 59101

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230-2510

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • Columbia Basin Hematology and Oncology

    Kennewick, Washington, 99336

  • Central Georgia Cancer Care

    Macon, Georgia, 31088

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • The West Clinic

    Memphis, Tennessee, 38120

  • University of Miami

    Miami, Florida, 33136

  • Weill Cornell Medical Center

    New York, New York, 10021

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97225

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78217

  • Texas Oncology- Tyler

    Tyler, Texas, 75702

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Single-Arm Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer

The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.

Read the detailed description

This is a multicenter, single-arm, Phase 2 trial to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2)-negative breast cancer. A total of 52 adult female subjects will be enrolled and treated with eribulin mesylate (1.4 mg/m2 as an intravenous [i.v.] infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle).

Being tested
Eribulin mesylate
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Eribulin mesylateDrug

    Eribulin mesylate 1.4 mg/m2 will be administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Study groups in NCT01268150
Study groupRoleWhat they receive
ExperimentalExperimentalNot described
Receives: Drug: Eribulin mesylate

What is being measured

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

  1. Objective Response Rate (ORR)

    The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR

    Measured: Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years

Secondary outcomes (3)

  1. Time to First Response (CR or PR)

    Time to first response was defined for participants whose BOR was a CR or PR. Analysis was based on the Kaplan-Meier estimated number of months to CR or PR. This statistical analysis method measures the effect of study drug on CR or PR.

    Measured: Treatment Phase (Day 1 Cycle 1) to earliest date of confirmed objective response (CR or PR), assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years

  2. Duration of Response

    Duration of response was measured for participants who were responders only, had attained a BOR that was CR or PR. The duration of response was measured from time that response criteria for CR or PR (whichever was recorded first) were first met until the date that progressive disease (PD) or death from any cause was first objectively documented. Participants who did not have PD were censored on the day of their last tumor assessment. Duration of response was summarized for the responders using Kaplan-Meier estimation method. This statistical analysis method measures the effect of study drug on the length of response time.

    Measured: First date of CR or PR to PD or Death from any cause, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years

  3. Progression-Free Survival (PFS)

    PFS was defined as the time from the date of the first dose of study drug until the date of first documentation of PD or date of death from any cause, whichever occurred first. Participants who died without reported PD were considered to have progressed on the day of their death. Participants who were lost to follow-up or alive and without reported PD at the end of study were censored on the date of their last tumor assessment. Participants without evidence of PD upon discontinuation of study drug during the Extension Phase returned to the clinic for disease evaluation and PFS calculation every 12 weeks until PD was documented. PFS was analyzed using Kaplan-Meier product-limit estimates. This statistical analysis method measures the effect of study drug on PFS.

    Measured: Treatment Phase (Day 1 Cycle 1) to date of progressive disease or death, whichever occurred first, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years

Timeline

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

  1. First posted29 Dec 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionMar 2012
  4. Study completionAug 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01268150
Sponsor's protocol ID
E7389-A001-206
Status last verified
Jun 2016
First submitted
28 Dec 2010
Last updated
22 Jun 2023

Publications

  • McIntyre K, O'Shaughnessy J, Schwartzberg L, Gluck S, Berrak E, Song JX, Cox D, Vahdat LT. Phase 2 study of eribulin mesylate as first-line therapy for locally recurrent or metastatic human epidermal growth factor receptor 2-negative breast cancer. Breast Cancer Res Treat. 2014 Jul;146(2):321-8. doi: 10.1007/s10549-014-2923-9. Epub 2014 Apr 4.

    PubMed 24699910

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eribulin mesylate in people with Locally Recurrent and Metastatic Breast Cancer ( HER2 Negative), run by Eisai Inc. at 17 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 12 inclusion and 10 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 9 Aug 2016). 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 (ORR) (time frame: Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years). 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 NCT01268150, 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 22 Jun 2023.

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