A Multi-Institutional Phase II Pilot Trial With Weekly Docetaxel and Herceptin as First or Second Line Therapy for HER2/Neu Overexpressing Metastatic Breast Cancer
OBJECTIVES: I. Determine the objective response rate of women with HER2-neu overexpressing
recurrent or metastatic breast cancer treated with trastuzumab (Herceptin) in combination
with docetaxel. II. Determine the toxicity of this treatment regimen in these patients. III.
Determine the duration of response to this treatment regimen in these patients. IV.
Determine the time to progression in these patients after receiving this treatment regimen.
V. Compare HER2-neu overexpression as determined by fluorescent in situ hybridization (FISH)
versus immunohistochemistry, and correlate these findings with response to this treatment
regimen in these patients. VI. Correlate HER2-neu activation by immunohistochemistry and the
extracellular domain of HER2-neu by ELISA with response to this treatment regimen in these
OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30 minutes weekly
for 6 weeks plus trastuzumab (Herceptin) IV over 30-90 minutes weekly for 8 weeks. Treatment
continues every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 3 months, every 3 months for 9 months, and then every 6
PROJECTED ACCRUAL: A total of 18-34 patients will be accrued for this study.
Primary Purpose: Treatment
Ingrid Mayer, MD
Vanderbilt-Ingram Cancer Center
United States: Federal Government
VICC BRE 9823
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Evanston Hospital||Evanston, Illinois 60201-1781|
|Providence Hospital||Mobile, Alabama 36608|
|Owensboro Medical Health System||Owensboro, Kentucky 42303|
|Memorial Health Care System||Chattanooga, Tennessee 37404|
|Erlanger Health Systems||Chattanooga, Tennessee 37403|
|Williamson Medical Center||Franklin, Tennessee 37067|
|Jackson-Madison County Hospital||Jackson, Tennessee 38301|
|Tennessee Cancer Specialists||Knoxville, Tennessee 37920|
|Methodist/Thompson Oncology Research||Knoxville, Tennessee 37916|
|Boston Baskin Cancer Group||Memphis, Tennessee 38104|
|St. Thomas Health Services||Nashville, Tennessee 37205|
|Methodist Medical Center of Oak Ridge||Oak Ridge, Tennessee 37831|