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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251095
Recruitment Status : Terminated (Failed primary endpoint)
First Posted : November 9, 2005
Last Update Posted : June 4, 2009
Information provided by:
Achieve Life Sciences

November 8, 2005
November 9, 2005
June 4, 2009
September 2005
September 2007   (Final data collection date for primary outcome measure)
  • Objective response rates [ Time Frame: Based on enrollment ]
  • Toxicities [ Time Frame: Based on enrollment ]
  • Objective response rates
  • Toxicities
Complete list of historical versions of study NCT00251095 on Archive Site
  • Median overall survival [ Time Frame: Based on enrollment ]
  • Progression-free survival [ Time Frame: Based on enrollment ]
  • Time-to-disease progression [ Time Frame: Based on enrollment ]
  • Median overall survival
  • Progression-free survival
  • Time-to-disease progression
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Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer
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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasm
  • Drug: Taxol
  • Drug: TOCOSOL Paclitaxel
    100 mg/m2/week
  • Active Comparator: Taxol
    Taxol 80mg/m2/week
    Intervention: Drug: Taxol
  • Experimental: TOCOSOL
    TOCOSOL Paclitaxel
    Intervention: Drug: TOCOSOL Paclitaxel
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2007
September 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with histologic diagnosis of breast carcinoma
  • Stage IV (M1) disease
  • Adult (18 years of age or older) patients

Exclusion Criteria:

  • Patients treated with a taxane within the past year
  • Patients whose tumor tissue is known to show over expression of HER2/neu
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Monica S. Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals
Achieve Life Sciences
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Not Provided
Achieve Life Sciences
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP