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

Eisai Inc.61 sites in 1 country298 target enrollmentOctober 2005

ConditionsBreast Cancer

InterventionsE7389

DrugsE7389

Overview

Phase: Phase 2
Intervention: E7389
Conditions: Breast Cancer
Sponsor: Eisai Inc.
Enrollment: 298
Locations: 61
Primary Endpoint: Objective Response Rate
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of E7389 in Patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine as prior therapy, and who are refractory to the last prior therapy for their disease.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

September 2007

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Eisai Inc.

Eligibility Criteria

Inclusion Criteria

•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.
•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.
•Patients with human epidermal growth factor receptor 2 (HER2/neu) over-expressing tumors must additionally have been treated with trastuzumab.
•Patients with estrogen receptor-expressing tumors may have additionally been treated with estrogen-specific therapy.
•Prior hormonal therapy, biological therapy, (eg, trastuzumab, bevacizumab), or immunotherapy, is not to be counted as one of the 2 to 5 prior chemotherapy regimens allowed. However, hormonal therapy must be discontinued one week before administration of E7389, and biological therapy must be discontinued two weeks before E7389 administration.
•Patients who are being treated with bisphosphonates when they enter the study are allowed to continue the medication as long as the dosing does not change. In case a change in dosing is deemed necessary, the case needs to be discussed with the Sponsor.
•Progression on or within six months of the last regimen for advanced disease, documented by the following:

Exclusion Criteria

•Patients must not have received chemotherapy, radiation, or biologic therapy within two weeks, hormonal therapy within one week, or trastuzumab within three weeks, before E7389 treatment start.
•Patients must not have received 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).
•Patients must not have pre-existing neuropathy \> Grade
•Patients must not have participated in a prior E7389 clinical trial.

Arms & Interventions

1

Intervention: E7389

Outcomes

Primary Outcomes

Objective Response Rate

Time Frame: Every two cycles

Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response 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).