ATEMPT 2.0 for Early stage HER2+ Breast Cancer - Clinical Trial

What is the Purpose of this Study?

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.

What is the Condition Being Studied?

Stage I HER2+ Breast Cancer

Who Can Participate in the Study?

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

Age Group

What is Involved?

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

Study Details

Full Title
A randomized phase II trial of adjuvant trastuzumab emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel in combination with subcutaneous trastuzumab for Stage I HER2-positive breast cancer (ATEMPT 2.0)
Principal Investigator
Protocol Number
IRB: PRO00110505
NCT: NCT04893109
Phase II
Enrollment Status
Open for Enrollment