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. - E7389-G000-211

Eisai Limited0 sites300 target enrollmentApril 12, 2006

Conditionsocally advanced or metastatic breast cancer MedDRA version: 8.1Level: PTClassification code 10055113

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ocally advanced or metastatic breast cancer
Sponsor: Eisai Limited
Enrollment: 300
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 12, 2006

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Eisai Limited

Eligibility Criteria

Inclusion Criteria

•1\. 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.
•2\. 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

Exclusion Criteria

•1\. Patients who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week, before E7389 treatment start.
•2\. 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).
•3\. Prior treatment with mitomycin C or nitrosourea, or prior stem cell transplantation.
•4\. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
•5\. Patients with brain or subdural metastases are not eligible,except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment with E 7389\.Any signs(eg,radiologic) and/or symptoms from their brain metastases must be stable for at least 4 weeks
•6\. Patients with meningeal carcinomatosis.
•7\. Patients who require anti\-coagulant therapy, other than line patency, with warfarin or related compounds,and cannot be changed to heparin\-based therapy,are not eligible. If a patient is to continue on mini\-dose warfarin,then the prothrombin time(PT)/international normalized ration(INR) must be monitored closely.
•8\. 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 child bearing potential unless (1\) surgically sterile or (2\) using adequate measures of contraception(two forms of contraception,at least one being a barrier method) in the opinion of the investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non\-childbearing potential.
•9\. Severe/uncontrolled intercurrent illness/infection.
•10\. Significant cardiovascular impairment (history of congestive heart failure \>NYHA Grade II, unstabel angina or myocardial infarction within the past six month, or seriuos cardiac arrhythmia).