Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer.
Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer|
- Number of Participants Achieved Pathological Complete Remission [ Time Frame: Baseline to last treatment cycle (approximately 28 weeks, 4 cycles of 21-day intervals of Taxol and up to 4 cycles of FEC for 3-4 week intervals) ] [ Designated as safety issue: No ]Response criteria for Complete Remission defined as disappearance of all clinical evidence of active tumor by clinical evaluation, mammogram and/or ultrasound, and free of all symptoms.
|Study Start Date:||April 2001|
|Study Completion Date:||July 2011|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
Experimental: Herceptin + Taxol Followed by FEC
Herceptin starting 4 mg/kg intravenous (IV), then 2 mg/kg weekly for all other cycles neo-adjuvant chemotherapy and during FEC therapy for total 24 doses. Taxol 225 mg/m^2 continuous IV over 24 hours each cycle; Fluorouracil 500 mg/m^2 IV Days 1 at 3-4 week intervals; Cytoxan 500 mg/m^2 IV on Day 1; Epirubicin 75 mg/m^2 IV on Day 1. Four 21-day cycles.
Starting dose of 4 mg/kg by vein, then 2 mg/kg weekly after that until the end of all cycles of neo-adjuvant chemotherapy and during FEC therapy for a total of 24 doses.
Other Name: TrastuzumabDrug: Taxol
225 mg/m^2 by vein as a continuous infusion over 24 hours each cycle for a total of 4 cycles.
Other Name: PaclitaxelDrug: Fluorouracil
500 mg/m^2 by vein on Days 1 and 4 for 4 cycles at 3-4 week intervals.Drug: Cytoxan
500 mg/m^2 on Day 1 of each cycle for 4 cycles.
Other Names:Drug: Epirubicin
75 mg/m^2 IV on Day 1 of each cycle for 4 cycles.
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aman U Buzdar, MD||M.D. Anderson Cancer Center|