B47 A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer
To determine whether the addition of trastuzumab to chemotherapy (TC or ACï¿½WP) improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported as HER2-low by all HER2 testing performed.
Generally healthy women over 18 years of age, Histologically confirmed invasive breast cancer, HER2-low by IHC staining, Undergone a total mastectomy or a breast-conserving surgery (lumpectomy) with clear margins, Undergone a nodal evaluation, No metastatic disease, Cannot have cancer in both breasts or previously in the opposite breast, Cannot have previously been treated with anthracyclines, taxanes or trastuzumab, No significant cardiact disease, No abnormal clinical lab results.
Eligible women with resected node-positive or high-risk node-negative invasive breast cancer determined to be HER2-low will be assigned to either standard chemotherapy alone or standard chemotherapy plus Trastuzumab for one year. The medical oncologist will select the chemotherapy regimen and the study will randomly assign, like flipping a coin, whether Trastuzumab will be given. Chemotherapy will given every 2-3 weeks for about 3-5 months. If Trastuzumab is given, it will be given every 3 weeks for 1 year. We will follow each subject for about 10 years.
12/21/2013 04:02 AM