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.
Who Can Participate?
Eligibility
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.
- 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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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
- 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
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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)
Study Website
Principal Investigator
Gretchen
Kimmick
Protocol Number
PRO00110505
NCT ID
NCT04893109
Phase
II
Enrollment Status
OPEN TO ACCRUAL