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 enrollmentDecember 9, 2005

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Eisai Limited
Enrollment: 300
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 9, 2005

End Date

TBD

Last Updated

14 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. A tissue sample from the diagnostic biopsy, paraffin block, cytological specimen, or slides obtained from these must be available for confirmation of diagnosis. To verify the diagnosis, patients need to have a counterstained,
•glass\-covered section of the fixed, paraffin\-embedded sample of their primary tumor.
•To analyze the gene expression pattern and screen for mutations in the genes encoding for tubulins and tubulin\-regulating proteins in their tumors, patients need to have one of 3 types of samples (for full details please see protocol).
•2\. Patients with locally advanced or metastatic disease who have received at least two (and not more than four) prior therapeutic regimens for breast cancer, at least one of which was administered for treatment of locally advanced or metastatic disease. Prior therapy must by 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 HER2/neu over\-expressing tumors must additionally have been
•treated with trastuzumab
•Patients with estrogen receptor\-expressing tumors may have additionally been

Exclusion Criteria

•1\. Patients who have received chemotherapy, radiation, or hormonal therapy within two weeks, or trastuzumab within three weeks, before E7389 treatment start.
•2\. Radiation therapy encompassing \>10% 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 known presence of brain metastasis.
•6\. Patients with meningeal carcinomatosis.
•7\. Patients who require therapeutic anti\-coagulant therapy with warfarin or related compounds; mini\-dose warfarin for catheter related thrombosis prophylaxis is permitted.
•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 n 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, unstable angina or myocardial infarction within the past six month, or serious cardiac arrhythmia).