Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer

Last updated: June 2, 2009
Sponsor: Achieve Life Sciences
Overall Status: Terminated

Phase

3

Condition

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT00251095
SON-8184-1075
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer. The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with histologic diagnosis of breast carcinoma

  • Stage IV (M1) disease

  • Adult (18 years of age or older) patients

Exclusion

Exclusion Criteria:

  • Patients treated with a taxane within the past year

  • Patients whose tumor tissue is known to show over expression of HER2/neu

Study Design

Total Participants: 821
Study Start date:
September 01, 2005
Estimated Completion Date:
September 30, 2007

Study Description

Female patients with first or second line metastatic breast cancer will be randomized to receive either weekly TOCOSOL Paclitaxel or weekly Taxol (paclitaxel injection). Patients will undergo radiographic imaging of their disease to assess response to therapy. The primary endpoint of this study is a comparison of the objective response rates observed in patients receiving TOCOSOL Paclitaxel, to those receiving Taxol. Time-to-disease progression and overall survival will also be compared. The toxicities of the two treatment regimens will be compared.

Connect with a study center

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California 94704
    United States

    Site Not Available

  • Desert Hematology Oncology Medical Group

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Stockton Hematology Oncology

    Stockton, California 95204
    United States

    Site Not Available

  • Florida Cancer Specialists

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Mountain State Tumor Institute

    Boise, Idaho 83712
    United States

    Site Not Available

  • Southfield Oncology Institute, Inc

    Southfield, Michigan 48076
    United States

    Site Not Available

  • Oncology Care Associates

    St Joseph, Michigan 49085
    United States

    Site Not Available

  • Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Essex Oncology of North Jersey

    Belleville, New Jersey 07109
    United States

    Site Not Available

  • Mid Dakota Clinic

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Hematology Oncology Consultants, Inc

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Chattanooga Oncology & Hematology Associates, PC

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • The Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas 79410
    United States

    Site Not Available

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