The purpose of this study is to determine the effectiveness and safety of administering Herceptin in combination with Taxol (paclitaxel) in the treatment of women with HER2-positive, early stage breast cancer prior to surgery.
Patients will receive Herceptin intravenously once weekly for 12 weeks, and Taxol intravenously every 3 weeks (week 1, week 4, week 7 and week 10). After 12 weeks of treatment, breast surgery will be performed (either a lumpectomy or a mastectomy). Once patients have recovered from the surgery, they will receive adriamycin and cytoxan every 3 weeks for 4 cycles (12 weeks total). After Herceptin and Taxol therapy, tumor assessment will be performed along with an echocardiogram and mammogram. At the time of surgery, re-assessment of the tumor will be done. Blood work will be performed on day one of each chemotherapy cycle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Given intravenously once weekly for 12 weeks prior to surgery.
Given intravenously every 3 weeks (weeks 1, 4, 7, and 10) before surgery.
Given every three weeks for 12 weeks after surgery.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
To determine the response of HER2-positive breast cancer to treatment with Herceptin and Taxol prior to surgery
To examine the safety of Herceptin and Taxol therapy followed by surgery and chemotherapy
Time frame: 3 years
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Given every three weeks for 12 weeks after surgery.