Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00038402|
Recruitment Status : Completed
First Posted : May 31, 2002
Last Update Posted : July 20, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Herceptin Drug: Taxol Drug: Fluorouracil Drug: Cytoxan Drug: Epirubicin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer|
|Study Start Date :||April 2001|
|Actual Primary Completion Date :||November 2004|
|Actual Study Completion Date :||July 2011|
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: Trastuzumab
225 mg/m^2 by vein as a continuous infusion over 24 hours each cycle for a total of 4 cycles.
Other Name: Paclitaxel
500 mg/m^2 by vein on Days 1 and 4 for 4 cycles at 3-4 week intervals.
500 mg/m^2 on Day 1 of each cycle for 4 cycles.
75 mg/m^2 IV on Day 1 of each cycle for 4 cycles.
- 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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038402
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aman U Buzdar, MD||M.D. Anderson Cancer Center|