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 carolina.morales@duke.edu.

Age Group
Adults

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
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment