ATEMPT 2.0 for Early stage HER2+ Breast Cancer

We are doing this study to find out if an investigational drug called T-DM1 (the study drug) is an effective treatment for HER2+ breast cancer when it is given as part of a regimen with trastuzumab injections. We will compare this regimen to the standard treatment of paclitaxel and trastuzumab.

Stage I HER2+ Breast Cancer

Adults who:

• Are diagnosed with stage I HER2+ breast cancer
• Have had or are planning to have surgery for their breast cancer
• Do not have cancer in the lymph nodes
• Have not previously used paclitaxel

For more information about who can join this study, please contact the study team at carolina.morales@duke.edu.

If you choose to join this study, you will:

• Get a random assignment (like a coin flip) to 1 of 2 groups
• One group will get the study drug as an infusion (IV) and trastuzumab thigh injections
• The other group will get IV paclitaxel and trastuzumab thigh injections (the standard therapy)
• Have blood draws
• Have imaging scans
• Have heart scans (EKG and echocardiogram)
• Answer questionnaires