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

Stopped early · Phase 3

Conditions studied: Breast Neoplasm

In brief

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.

Key facts

Study ID

NCT00251095

Run by

Achieve Life Sciences

People needed

821

Starts

2005-09-01

Expected to finish

2007-09-01

Last updated by the study team

2009-06-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Patients treated with a taxane within the past year
• Patients whose tumor tissue is known to show over expression of HER2/neu

Where it is running

• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• Desert Hematology Oncology Medical Group — Rancho Mirage, California, United States
• Stockton Hematology Oncology — Stockton, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Mountain State Tumor Institute — Boise, Idaho, United States
• Oncology Care Associates — Saint Joseph, Michigan, United States
• Southfield Oncology Institute, Inc — Southfield, Michigan, United States
• Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Essex Oncology of North Jersey — Belleville, New Jersey, United States
• Mid Dakota Clinic — Bismarck, North Dakota, United States
• Hematology Oncology Consultants, Inc — Columbus, Ohio, United States
• Chattanooga Oncology & Hematology Associates, PC — Chattanooga, Tennessee, United States
• The Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Joe Arrington Cancer Research and Treatment Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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