Breast Cancer Clinical Trial

Clinical Trial Finder Breast Cancer Trials

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

See Locations Near You

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

821

Study ID:

NCT00251095

Recruitment Status:

Terminated

Sponsor:

Achieve Life Sciences

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 14 Locations for this study

See Locations Near You

Alta Bates Comprehensive Cancer Center
Berkeley California, 94704, United States
Desert Hematology Oncology Medical Group
Rancho Mirage California, 92270, United States
Stockton Hematology Oncology
Stockton California, 95204, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Mountain State Tumor Institute
Boise Idaho, 83712, United States
Southfield Oncology Institute, Inc
Southfield Michigan, 48076, United States
Oncology Care Associates
St Joseph Michigan, 49085, United States
Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Essex Oncology of North Jersey
Belleville New Jersey, 07109, United States
Mid Dakota Clinic
Bismarck North Dakota, 58501, United States
Hematology Oncology Consultants, Inc
Columbus Ohio, 43235, United States
Chattanooga Oncology & Hematology Associates, PC
Chattanooga Tennessee, 37404, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
Load More

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

821

Study ID:

NCT00251095

Recruitment Status:

Terminated

Sponsor:


Achieve Life Sciences

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
Clinical Trials for Breast Cancer
Have You Been Diagnosed With Late-Stage Breast Cancer? Know That You Have Treatment Options.
×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider