A Randomized Phase II Study of Adjuvant Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination with Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT Trial)
The purpose of this research study is to compare treatment with Trastuzumab Emtansine alone to treatment with Trastuzumab plus paclitaxel (Taxol) to see which one is better. We also would like to learn what effects the study treatment has on you and your quality of life. The standard treatment for HER2+ breast cancer now includes trastuzumab (Herceptin®) and paclitaxel. Trastuzumab Emtansine is a new anti HER2 drug is approved by the FDA in advanced HER 2 + breast cancer, but its use as done in this study, in early breast cancer, is investigational.
Patients with HER2 + (either 3+ by IHC and /or FISH positive) node negative primary breast cancer will be considered eligible. Patients must have completed surgery for their breast cancer (either lumpectomy or mastectomy).
Before starting treatment on this study, you will need to sign a consent form. Blood tests, EKG, heart function test and testing of your breast cancer tissue to confirm HER2 status will be done before starting treatment. If the tests show that you are eligible for the study and you choose to take part, you will be randomized into one of the two groups:? Arm A: Trastuzumab Emtansine will be given intravenously every three weeks for a total of 17 doses (52 weeks).? Arm B: Taxol and Trastuzumab will be given intravenously every week for 12 doses. This will be followed by treatment with Trastuzumab alone every 3 weeks for total of 52 weeks.After treatment, the study team will keep track of your medical condition for the next 5 years. We do this by regular visits every 6 months for 3 years, and then once a year for the next two years.The investigational drug Trastuzumab Emtansine will be supplied by the study.
09/30/2014 04:03 AM