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Breast NeoplasmsPhase 2NCT00080197

Study to Evaluate the Efficacy, Safety, and Tolerability of E7070 in Metastatic Breast Cancer Patients

A Phase 2 study testing E7070 in people with Breast Neoplasms and Metastases, run by Eisai Inc. at 35 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 determine if E7070 is an efficacious, safe, and tolerable treatment for patients with metastatic breast cancer who have failed, or could not tolerate, prior treatments with an anthracycline, a taxane, and capecitabine. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms, Metastases
What is being tested?
E7070
How many people
250 participants
Where
35 sitesin 2 countries
Study dates
Feb 2004to May 2005
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Patients must be female,
  • Patients must have histologically or cytologically confirmed metastatic breast cancer,
  • Patients must either have tumors that are resistant/refractory to chemotherapy with an anthracycline, a taxane, capecitabine, and appropriate Herceptin therapy, or tumors that cannot be treated with these agents due to patient's treatment toxicity; therefore, patients must have received 2 prior chemotherapies but no more than 3 prior chemotherapies in the metastatic setting,
  • Patients must have at least one uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated,
  • Patients must be aged >= 18 years,
  • Patients must have a Karnofsky Performance Status of >= 70%,
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  • Patients must have a life expectancy of >= 3 months,
  • Patients must have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL, or if > 1.5 but <= 1.8 mg/dL, then a creatinine clearance of >= 45 mL/min,
  • Patients must have adequate bone marrow function as evidenced by absolute neutrophil count of >= 1.5 x 109/L, hemoglobin >= 9.0 g/dL, and platelet count >= 100 x 109/L,
  • Patients must have adequate liver function as evidenced by bilirubin of <= 1.5 times the upper limits of normal (ULN); alkaline phosphatase <= 3 times ULN and alanine transaminase (ALT) and aspartate transaminase (AST) <= 3 times ULN, unless related to liver metastasis, in which case <= 5 x ULN,
  • Patients must have serum electrolytes including calcium (corrected for albumin), magnesium, and potassium (corrected) within normal limits,
  • Patients must be willing and able to complete the FACT-B questionnaire,
  • Patients must be willing and able to comply with the study protocol for the duration of the study, and
  • Patients must give 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 metastatic disease that can be completely surgically resected,
  • Patients who received adjuvant taxane must not have experienced disease progression within 12 months of beginning that therapy,
  • Patients must not have received chemotherapy, hormonal therapy, or Herceptin within 2 weeks of E7070 treatment start and must have recovered from any chemotherapy-related or other therapy-related toxicity at study entry,
  • Patients must not have received investigational drugs including immunotherapy, gene therapy, or other biologic therapy; antineoplastic therapy; or radiation therapy (other than required for palliation of bone pain or chest ulceration) within 2 weeks of E7070 treatment,
  • Patients must not have received prior treatment with Mitomycin C or nitrosoureas,
  • Patients must not have undergone high dose chemotherapy with hematopoietic stem cell rescue,
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  • Patients must not have untreated brain metastases (Patients who have been treated for central nervous system (CNS) metastases must be asymptomatic and radiologically stable [not receiving radiation] and must not have been receiving steroids for 4 weeks prior to entry.
  • Patients without known CNS metastases who are symptomatic for CNS metastasis must be evaluated with a CT scan or MRI scan prior to E7070 treatment.),
  • Patients must not have had major surgery without full recovery within 4 weeks of E7070 treatment start,
  • Patients must not have pulmonary lymphatic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen,
  • Patients must not have leptomeningeal metastasis,
  • Patients must not have evidence of clinically relevant ascites or pleural effusion requiring more than one isolated paracentesis or pleurocentesis per month prior to study start,
  • Patients must not be expected to require more than one isolated paracentesis or pleurocentesis per month during the study for the treatment of clinically relevant ascites or pleural effusion,
  • Patients must not be pregnant or breast-feeding and must practice adequate contraception if not surgically sterile,
  • Patients must not have severe medically uncontrolled intercurrent illness/infection,
  • Patients must not have had unstable angina or myocardial infarction in the past 6 months,
  • Patients must not have serious cardiac arrhythmia or symptomatic congestive heart failure >= Grade II (NYHA classification),
  • Patients must not have a history of prolonged QT, QTc > 470 ms (Bazett's correction) at entry, or history of torsade de pointes,
  • Patients must not have recent history (<= 12 months) of active or chronic viral hepatitis,
  • Patients must not have organ allografts,
  • Patients must not have known history of HIV positivity,
  • Patients must not have a history of hypersensitivity to sulfonamides,
  • Patients must not have a history of uncontrolled seizures,
  • Patients must not have had a prior malignancy, other than carcinoma in situ of the cervix or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence, or
  • Patients must not have other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States34 sites

  • Study site

    Albany, New York

  • Study site

    Austin, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Chicago, Illinois

  • Study site

    Clairton, Pennsylvania

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Fairfax, Virginia

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Fredericksburg, Texas

  • Study site

    Greenville, South Carolina

  • Study site

    Hoover, Alabama

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Irving, Texas

  • Study site

    Kettering, Ohio

  • Study site

    Minneapolis, Minnesota

  • Study site

    Ocoee, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Overland Park, Kansas

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Sedona, Arizona

  • Study site

    Skokie, Illinois

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Torrington, Connecticut

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tyler, Texas

  • Study site

    Urbana, Illinois

  • Study site

    Vancouver, Washington

  • Study site

    Wexford, Pennsylvania

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Canada1 site

  • Study site

    Edmonton, Alberta

Other trials in Canada

About this study

Official title: An Open-Label Phase II Study of E7070 in Metastatic Breast Cancer Patients Previously Treated With an Anthracycline, a Taxane, and Capecitabine

The purpose of this study is to determine if E7070 is an efficacious, safe, and tolerable treatment for patients with metastatic breast cancer who have failed, or could not tolerate, prior treatments with an anthracycline, a taxane, and capecitabine.

Being tested
E7070
Keywords
Breast Cancer, Cancer of the Breast
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • E7070Drug

What is being measured

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

  1. Objective Response Rate

Secondary outcomes (6)

  1. Duration of Response

  2. Time-to-Progression

  3. Overall Survival

  4. Safety

  5. Tolerability

  6. Quality of Life

Timeline

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

  1. First posted25 Mar 2004 (estimated)
  2. Study startFeb 2004
  3. Study completionMay 2005

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
250 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00080197
Sponsor's protocol ID
E7070-A001-211
Status last verified
Oct 2006
First submitted
24 Mar 2004
Last updated
11 Oct 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E7070 in people with Breast Neoplasms and Metastases, run by Eisai Inc. at 35 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 14 inclusion and 25 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 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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. 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 NCT00080197.

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 11 Oct 2006.

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