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COMPLETEDPHASE2

A Study of E7389 in Advanced/Metastatic Breast Cancer Patients

A Phase II Open Label Study of E7389 (Halichondrin B Analog) in Patients With Advanced/Metastatic Breast Cancer Previously Treated With Chemotherapy Including An Anthracycline and A Taxane

NCT00097721•Eisai Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if E7389 is a safe and effective treatment for advanced/metastatic breast cancer.

Detailed Description

The primary objective is to determine the response rate (RR) to E7389 monotherapy administered as an IV bolus of 1.4 mg/m\^2 on Days 1, 8, and 15 of a 28-Day cycle and on Days 1 and 8 of a 21-day cycle in patients with advanced/metastatic breast cancer treated with chemotherapy including an anthracycline and a taxane, with previously documented progression during or within six months following the last dose of prior chemotherapy. The secondary objectives are to evaluate: * The safety and tolerability of E7389 monotherapy in this patient population; * The antitumor activity of E7389 as determined by duration of response, time to progression, and overall survival; * Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire/tumor-related symptom improvement or worsening measured by pain intensity on a visual analog scale (VAS), analgesics consumption, weight changes and performance status (PS); * Tumor pharmacogenetics and their possible relationship to response (assessment of beta-tubulin isotype mRNA on biopsy sample) in patients who have signed a separate consent form

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female patients with histologically or cytologically confirmed carcinoma of the breast
•Patients with advanced/metastatic disease that is not amenable to curative therapy (either surgery or radiation therapy)
•Patients must have measurable disease by the RECIST criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter (LD) by spiral computer tomography (CT) scan, or at least 20 mm by standard techniques; If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a cytological or histological confirmation of breast carcinoma is required.
•Patients must have had prior treatment with an anthracycline and a taxane (either sequential or in combination) and may have had prior treatment with other agents as well.
•Patients must have progressed within six months of the last dose of chemotherapy, or experienced disease progression while receiving chemotherapy for advanced/metastatic disease.
•Resolution of all chemotherapy or radiation-related toxicities to less than grade 1 severity
•Age ≥ 18 years
•Eastern Cooperative Oncology Group (ECOG) Performance Status (APPENDIX 4) of 0 or 1
•Life expectancy of ≥ 3 months
•Adequate renal function as evidenced by serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 50 mL/minute (min) per the Cockcroft and Gault formula
+18 more criteria

Exclusion Criteria

•Patients who have received chemotherapy, radiation, hormonal therapy, or Herceptin within 2 weeks of E7389 treatment start
•Radiation therapy encompassing \> 10% of marrow
•Failure to recover from any chemotherapy related or other therapy related toxicity at study entry that is deemed to be clinically significant by the study investigator
•Prior treatment with Mitomycin C or nitrosoureas
•Prior high dose chemotherapy with hematopoietic stem cell rescue in the past two years
•Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen

Locations (16)

Jonesboro, Arkansas, United States

Deer Park, California, United States

La Verne, California, United States

Pasadena, California, United States

Pomona, California, United States

Brooksville, Florida, United States

New Port Richey, Florida, United States

Plantation, Florida, United States

New Orleans, Louisiana, United States

Southaven, Mississippi, United States

Key Dates

Start Date

September 1, 2004

Primary Completion Date

November 1, 2006

Completion Date

November 1, 2006

Last Updated

April 22, 2013

Enrollment

104

ACTUAL participants

Conditions

Breast Neoplasms

Interventions

E7389

DRUG

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

RECRUITINGPHASE2

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

NCT06797635

Breast NeoplasmsBreast Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 22, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of E7389 in Advanced/Metastatic Breast Cancer Patients

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Dissemination of BREASTChoice AIM1-B

Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B