ATEMPT 2.0 for Early stage HER2+ Breast Cancer

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
Professor of Medicine
Protocol Number
IRB: PRO00110505
NCT: NCT04893109
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL