Clinical Trials Logo
  1. Home
  2. Breast Neoplasm
  3. NCT00251095

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

Breast Neoplasm Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00251095
Study type Interventional
Source OncoGenex Technologies
Contact
Status Terminated
Phase Phase 3
Start date September 2005
Completion date September 2007
View Details
See also
  Status Clinical Trial Phase
Completed NCT03273426 - Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy. N/A
Recruiting NCT04583124 - Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO) N/A
Active, not recruiting NCT04489173 - TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer Phase 2
Recruiting NCT02913573 - Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction Phase 2
Completed NCT03124095 - Combined Training Intervention for Women Who Underwent Primary Treatment for Breast Cancer N/A
Completed NCT05576545 - Develop and Evaluate the Effectiveness of a Self-Care Smartphone Application on the Self-Efficacy, and Resilience Among Newly Diagnosed Breast Cancer Patients Undergoing Treatment N/A
Active, not recruiting NCT03625635 - Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment N/A
Recruiting NCT04799535 - Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
Withdrawn NCT03266562 - Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography N/A
Completed NCT00530868 - Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer Phase 2
Recruiting NCT06255808 - Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
Completed NCT04640220 - Improvement of Range of Motion in Frozen Shoulder in Breast Cancer Survivors N/A
Completed NCT02970682 - SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer Phase 2
Completed NCT02316561 - Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer N/A
Terminated NCT00638963 - Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2) Phase 2
Terminated NCT00249301 - A Study of MLN8054 in Patients With Advanced Solid Tumors Phase 1
Not yet recruiting NCT06056414 - Study of Anxiety After a Session of Energy Resonance by Cutaneous Stimulation N/A
Recruiting NCT05427071 - Magnetic Marker Localization for Occult Breast Cancer and Target Axillary Dissection in Node-positive Breast Cancer Post-neoadjuvant Chemotherapy N/A
Recruiting NCT03740893 - PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition and/or Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Chemotherapy Resistant Residual Triple Negative Breast Cancer Phase 2
Active, not recruiting NCT03935282 - Assessing Effectiveness and Implementation of an EHR Tool to Assess Heart Health Among Survivors N/A