About this trial
This study looks at how long to give HER2-targeted treatment for breast cancer. It compares 6 months of therapy to 12 months for patients who had a complete response after chemotherapy. The goal is to see if 6 months is just as effective as the longer treatment, while also checking how it affects patients’ quality of life.
This is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. The trial hopes to include about 1,524 participants. This trial is not using any FDA-regulated drugs.
Who can join
Adults aged 18 and older can join this study. It is open to both men and women. Participants must have early-stage HER2-positive breast cancer and have completed chemotherapy without any remaining invasive disease. The trial team will confirm who is eligible to participate.
Conditions
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2+ Breast Cancer
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into one of two groups. One group will receive 12 months of HER2-targeted therapy, while the other group will receive 6 months. Both groups will receive treatments like trastuzumab and possibly pertuzumab, along with regular check-ups and tests during the trial.
Where
This trial is running at 667 locations in the United States. 585 of them are currently recruiting.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Adams Cancer Center
Gettysburg, Pennsylvania
Advocate Christ Medical Center
Oak Lawn, Illinois
Advocate Good Samaritan Hospital
Downers Grove, Illinois
Advocate Good Shepherd Hospital
Barrington, Illinois
Advocate Illinois Masonic Medical Center
Chicago, Illinois
Advocate Lutheran General Hospital
Park Ridge, Illinois
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois
The first 8 of 667 sites are listed here. The registry record has the full list.