Completed

E7070 Treatment for Metastatic Breast Cancer Patients Previously Treated with Anthracycline, Taxane, and Capecitabine

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What is being tested

Data Collection

Who is being recruted

Breast Diseases+7

+ Breast Neoplasms

+ Neoplasm Metastasis

Over 18 Years
+38 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorEisai Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

This study focuses on a drug called E7070 and its potential benefits for individuals with metastatic breast cancer. Metastatic breast cancer is a form of breast cancer that has spread to other parts of the body. This study is specifically for those who have previously undergone treatment with an anthracycline, a taxane, and capecitabine, but these treatments were either not effective or caused intolerable side effects. The main goal of this research is to determine if E7070 can be a safe and effective treatment option for these patients, potentially improving their care and quality of life. In this study, participants will receive E7070 as part of their treatment. The study is designed to measure how well the drug works, specifically looking at the 'Objective Response Rate'. This refers to the proportion of patients who show a significant reduction in their tumor size after treatment. The study will also monitor the safety and tolerability of E7070, keeping track of any side effects or complications that may occur.

Official TitleAn Open-Label Phase II Study of E7070 in Metastatic Breast Cancer Patients Previously Treated With an Anthracycline, a Taxane, and Capecitabine
NCT00080197
Principal SponsorEisai Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue Diseases

Criteria

14 inclusion criteria required to participate
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
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24 exclusion criteria prevent from participating
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers