Title (NSABP B-47) A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphomide or Four Cycles of Doxorubicin Plus Cyclophosphomide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2 -Low Invasive Breast Cancer
Principal Investigator Ellis Levine, MD
Study Number 195511
The purpose of this study is to learn if adding a targeted therapy, trastuzumab, to standard treatment with chemotherapy for early stage , HER2-low breast cancer, will prevent breast cancer from returning.
A second purpose of this study is to learn if adding trastuzumab to treatment with chemotherapy will help women with HER2 low breast cancer live longer.
Another goal of this study is to find out how the drugs used in this study affect menstrual cycles and if these changes in menstrual cycles have any effect on breast cancer. As part of this study goal, you will be asked to allow blood samples to be collected.
- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
- All of the following must be met: By pathologic evaluation, primary tumor must be pT1-3; By pathological evaluation, ipsilateral nodes must be pN0, pN1, pN2a, pN2b, pN3a or pN3b
- HER2 status of the primary tumor must be evaluated prior to randomization; all testing performed must indicate that the tumor is HER2.
- The patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy).
- The patient must have completed one of the procedures for evaluation of pathologic nodal status listed, Sentinel lymphadenectomy alone, if pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b. For patients who will receive the TC chemotherapy regimen, the LVEF must be 50% regardless of the cardiac imaging facility's lower limit of normal.
- LVEF assessment must be performed with 90 days prior to randomization.
- Primary tumor with any of the following HER2 testing results: IHC staining intensity of 0 or 3+.
- T4 tumors including inflammatory breast cancer.
- Definitive clinical or radiologic evidence of metastatic disease.
- Previous therapy with anthracyclines, taxanes, or trastuzumab for any malignancy.