About this trial
This study is looking at how well two different treatments work for people with newly diagnosed Stage I HER2-positive breast cancer. After surgery, participants will receive either trastuzumab-emtansine (T-DM1) followed by trastuzumab or paclitaxel combined with trastuzumab. The goal is to see if T-DM1 has fewer side effects and better long-term outcomes than the traditional treatment.
The trial's ID number is NCT04893109. It is a Phase 2 trial, which means it is looking at how well the treatment works and how safe it is. About 500 people are expected to participate, and it is FDA-regulated.
Who can join
This trial is open to adults aged 18 and older, both men and women. Participants must have Stage I HER2-positive breast cancer and meet certain medical requirements. The trial team will confirm if someone is eligible to join.
Conditions
Breast Cancer, HER2-positive Breast Cancer
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed into one of two groups by chance. One group will receive T-DM1 and then trastuzumab, while the other will get paclitaxel along with trastuzumab. Everyone will be monitored closely during the treatment and for five years after.
Where
This trial is running at 53 locations in the United States. 47 of them are currently recruiting.
Berkshire Medical Center
Pittsfield, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Dana Farber at South Shore Hospital
Weymouth, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts
Dana-Farber at Milford
Milford, Massachusetts
Dana-Farber at St. Elizabeth's Medical Center
Brighton, Massachusetts
Dana-Farber Brigham Cancer Center - Foxborough
Foxborough, Massachusetts
Dana-Farber Cancer Insitute at Londonderry Hospital
Londonderry, New Hampshire
The first 8 of 53 sites are listed here. The registry record has the full list.