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Breast NeoplasmsPhase 2NCT00097721

A Study of E7389 in Advanced/Metastatic Breast Cancer Patients

A Phase 2 study testing E7389 in people with Breast Neoplasms, run by Eisai Inc. at 16 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 determine if E7389 is a safe and effective treatment for advanced/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 Neoplasms
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
104 participants
Where
16 sitesUnited States
Study dates
Sep 2004to Nov 2006
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
  • Patients with advanced/metastatic disease that is not amenable to curative therapy (either surgery or radiation therapy)
  • Patients must have measurable disease by the 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 cytological or histological confirmation of breast carcinoma is required.
  • Patients must have had prior treatment with an anthracycline and a taxane (either sequential or in combination) and may have had prior treatment with other agents as well.
  • Patients must have progressed within six months of the last dose of chemotherapy, or experienced disease progression while receiving chemotherapy for advanced/metastatic disease.
  • Resolution of all chemotherapy or radiation-related toxicities to less than grade 1 severity
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  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (APPENDIX 4) of 0 or 1
  • Life expectancy of ≥ 3 months
  • Adequate renal function as evidenced by serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 50 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 (a hemoglobin <10.0 g/dL would be acceptable if it can be corrected by growth factor or transfusion), 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)
  • Patients willing and able to complete the FACT-B questionnaire, Analgesic Diary, Pain VAS, and the tumor-related symptomatic assessment
  • Patients willing and able to comply with the study protocol for the duration of the study
  • A sample from the diagnostic biopsy (paraffin block) must be available
  • 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 who have received chemotherapy, radiation, hormonal therapy, or Herceptin within 2 weeks of E7389 treatment start
  • Radiation therapy encompassing > 10% of marrow
  • Failure to recover from any chemotherapy related or other therapy related toxicity at study entry that is deemed to be clinically significant by the study investigator
  • Prior treatment with Mitomycin C or nitrosoureas
  • Prior high dose chemotherapy with hematopoietic stem cell rescue in the past two years
  • Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
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  • Active symptomatic brain metastasis; Patients with central Nervous System (CNS) metastasis are considered eligible if they have completed local therapy and discontinued from corticosteroids for at least two weeks before starting treatment with E7389
  • Patients with meningeal carcinomatosis
  • Patients who require therapeutic anti-coagulant therapy with Warfarin or related compounds; Mini dose warfarin for catheter related thrombosis prophylaxis is permitted
  • Women who are pregnant or breast-feeding; Women of childbearing potential with either a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Severe /uncontrolled intercurrent illness/infection
  • Significant cardiovascular impairment (history of congestive heart failure > NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)
  • Patients with organ allografts
  • Patients with known positive HIV status
  • Patients who have had a prior malignancy, other than carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated ≥ 5 years previously with no subsequent evidence of recurrence
  • Patients with pre-existing neuropathy > Grade 1
  • Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative
  • Patients who participated in a prior E7389 clinical trial
  • Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Study site

    Amarillo, Texas

  • Study site

    Brooksville, Florida

  • Study site

    Deer Park, California

  • Study site

    Jonesboro, Arkansas

  • Study site

    La Verne, California

  • Study site

    Memphis, Tennessee

  • Study site

    Middletown, Ohio

  • Study site

    Missoula, Montana

  • Study site

    New Orleans, Louisiana

  • Study site

    New Port Richey, Florida

  • Study site

    Pasadena, California

  • Study site

    Plantation, Florida

  • Study site

    Pomona, California

  • Study site

    Richardson, Texas

  • Study site

    Southaven, Mississippi

  • Study site

    Syracuse, New York

Other trials in United States

About this study

Official title: A Phase II Open Label Study of E7389 (Halichondrin B Analog) in Patients With Advanced/Metastatic Breast Cancer Previously Treated With Chemotherapy Including An Anthracycline and A Taxane

The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.

Read the detailed description

The primary objective is to determine the response rate (RR) to E7389 monotherapy administered as an IV bolus of 1.4 mg/m^2 on Days 1, 8, and 15 of a 28-Day cycle and on Days 1 and 8 of a 21-day cycle in patients with advanced/metastatic breast cancer treated with chemotherapy including an anthracycline and a taxane, with previously documented progression during or within six months following the last dose of prior chemotherapy.

The secondary objectives are to evaluate:

  • The safety and tolerability of E7389 monotherapy in this patient population;
  • The antitumor activity of E7389 as determined by duration of response, time to progression, and overall survival;
  • Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire/tumor-related symptom improvement or worsening measured by pain intensity on a visual analog scale (VAS), analgesics consumption, weight changes and performance status (PS);
  • Tumor pharmacogenetics and their possible relationship to response (assessment of beta-tubulin isotype mRNA on biopsy sample) in patients who have signed a separate consent form
Being tested
E7389
Keywords
breast neoplasm, breast cancer, breast tumor
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

    The first cohort of subjects were to receive E7389 1.4 mg/m^2 as an intravenous (IV) bolus on Days 1, 8, and 15 of a 28-day cycle. A second cohort of subjects was added and were to receive E7389 1.4 mg/m^2 as an IV bolus on Days 1 and 8 of a 21-day cycle.

Study groups in NCT00097721
Study groupRoleWhat they receive
E7389ExperimentalNot described
Receives: Drug: E7389

What is being measured

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

  1. Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)

    Defined as the percentage of subjects with CR or PR 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: Confirmed 4 to 8 weeks after first observed

Secondary outcomes (4)

  1. Duration of Response

    Measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent progressive disease was objectively documented (taking as a reference for progressive disease the smallest measurements recorded since the treatment started).

    Measured: From CR or partial response PR (whichever recorded first) to date of recurrent or progressive disease

  2. Progression Free Survival

    Defined as the time from start of study drug administration until progressive disease or death from any cause during the study period in the absence of disease progression.

    Measured: From start of study drug administration to progressive disease or death

  3. Overall Survival

    Defined as the time from the start of study drug administration until death from any cause

    Measured: From start of study drug administration to death

  4. Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores

    The FACT-B questionnaire consists of 36 questions each scored from 0-4. The total score is calculated by summing these scores. The total possible range is from 0 to 144. The higher scores indicate a better health-related quality of life. This measures emotional, functional, physical, and social well being as well as concerns specific to patients with breast cancer.

    Measured: At Screening, Day 1 of each cycle, and 30 days after last dose of study drug

Timeline

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

  1. First posted30 Nov 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionNov 2006
  4. Study completionNov 2006

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
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00097721
Sponsor's protocol ID
E7389-A001-201
Status last verified
Apr 2013
First submitted
29 Nov 2004
Last updated
22 Apr 2013

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 Neoplasms, run by Eisai Inc. at 16 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 16 inclusion and 19 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 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 15 Mar 2013). 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?

Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Confirmed 4 to 8 weeks after first observed). 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 NCT00097721, 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 Apr 2013.

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