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Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Docetaxel
Epirubicin
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic breast cancer confirmed by biopsy. Received no previous chemotherapy for metastatic breast cancer. Prior hormonal therapy is acceptable. Measurable or evaluable disease. Able to perform activities of daily living without considerable assistance Adequate bone marrow, liver and kidney function Must be able to understand the nature of this study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years. Cardiac ejection fraction < 45%. Women who are pregnant or lactating. Patients with meningeal metastases are ineligible. Moderate peripheral neuropathy History of hypersensitivity reaction to Taxotere Males with metastatic breast cancer Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer

    Secondary Outcome Measures

    Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    May 2, 2011
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Aventis Pharmaceuticals, Pharmacia and Upjohn
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193024
    Brief Title
    Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer
    Official Title
    A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Terminated
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    October 2003 (Actual)
    Study Completion Date
    October 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Aventis Pharmaceuticals, Pharmacia and Upjohn

    4. Oversight

    5. Study Description

    Brief Summary
    The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.
    Detailed Description
    Upon determination of eligibility, all patients will receive: Docetaxel + Epirubicin Both drugs will be repeated at 21-day intervals

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    90 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Epirubicin
    Primary Outcome Measure Information:
    Title
    Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
    Secondary Outcome Measure Information:
    Title
    Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic breast cancer confirmed by biopsy. Received no previous chemotherapy for metastatic breast cancer. Prior hormonal therapy is acceptable. Measurable or evaluable disease. Able to perform activities of daily living without considerable assistance Adequate bone marrow, liver and kidney function Must be able to understand the nature of this study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years. Cardiac ejection fraction < 45%. Women who are pregnant or lactating. Patients with meningeal metastases are ineligible. Moderate peripheral neuropathy History of hypersensitivity reaction to Taxotere Males with metastatic breast cancer Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John D. Hainsworth, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16939953
    Citation
    Hainsworth JD, Yardley DA, Spigel DR, Meluch AA, Rinaldi D, Schnell FM, Greco FA. Docetaxel and epirubicin as first-line treatment for patients with metastatic breast cancer: a Minnie Pearl Cancer Research Network Phase II trial. Cancer Invest. 2006 Aug-Sep;24(5):469-73. doi: 10.1080/07357900600814060.
    Results Reference
    result

    Learn more about this trial

    Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer

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