Paclitaxel With or Without Trastuzumab Following Peripheral Stem Cell Transplantation in Treating Patients With Refractory Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Paclitaxel may stop the growth of breast cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to compare the effectiveness of paclitaxel with or without trastuzumab following peripheral stem cell transplantation in treating patients who have refractory stage IV breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Treatment of Refractory Stage IV Metastatic Breast Cancer With Weekly Paclitaxel or Weekly Paclitaxel and Herceptin Following Autologous/Syngeneic Stem Cell Transplant|
|Study Start Date:||January 1999|
|Study Completion Date:||October 2001|
|Primary Completion Date:||October 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the toxicity of paclitaxel with or without trastuzumab following high dose chemotherapy with autologous or syngeneic peripheral blood stem cell transplantation in patients with stage IV breast cancer. II. Assess the overall survival of these patients.
OUTLINE: Patients begin study treatment within 50-150 days after autologous or syngeneic peripheral blood stem cell transplantation. Patients are stratified according to overexpression of HER2-Neu (yes vs no), which determines the type of therapy. Arm I (overexpression of HER2-Neu): Patients receive paclitaxel IV over 60 minutes followed by the initial loading dose of trastuzumab IV over 90 minutes. If the loading dose is tolerated well, then patients receive maintenance trastuzumab IV over 30 minutes. Treatment with paclitaxel followed by maintenance trastuzumab repeats once every week for 12 weeks in the absence of disease progression or unacceptable toxicity. Arm II (no overexpression of Her2-Neu): Patients receive paclitaxel IV over 60 minutes once every week for 12 weeks. Patients with hormone receptor positive disease also receive antihormonal therapy (tamoxifen or anastrozole) as clinically indicated. Patients with isolated metastasis such as a single bone lesion may receive radiotherapy to that site after completion of study treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study over 2-3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004013
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||Leona A. Holmberg, MD, PhD||Fred Hutchinson Cancer Research Center|