About this trial
This trial looks at whether adding chemotherapy to ovarian function suppression and endocrine therapy helps women with early-stage breast cancer. It focuses on premenopausal patients with certain types of breast cancer. The goal is to see if this combination improves their chances of staying free from invasive breast cancer.
The trial's ID is NCT05879926. This is a Phase 3 trial, which means it is testing how well the treatment works and its safety. It is not regulated by the FDA for drugs or devices. The trial hopes to include about 3,960 participants.
Who can join
Women between 18 and 60 years old can join if they are premenopausal and meet specific health criteria. They must have a certain type of breast cancer and a specific recurrence score. The trial team will check if each person qualifies to participate.
The study team makes the final call on eligibility.
What happens in the study
Participants will be placed into two groups by chance. One group will receive ovarian function suppression along with an aromatase inhibitor for 5 years. The other group will receive chemotherapy followed by ovarian function suppression and an aromatase inhibitor for 5 years. Everyone will receive treatment.
Where
This trial is running at 1,214 locations in the United States. 1105 of them are currently recruiting.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Adams Cancer Center
Gettysburg, Pennsylvania
Addison Gilbert Hospital
Gloucester, Massachusetts
AdventHealth Altamonte
Altamonte Springs, Florida
AdventHealth Orlando
Orlando, Florida
Advocate Christ Medical Center
Oak Lawn, Illinois
Advocate Good Samaritan Hospital
Downers Grove, Illinois
Advocate Good Shepherd Hospital
Barrington, Illinois
The first 8 of 1,214 sites are listed here. The registry record has the full list.