About this trial
This trial looks at how well active monitoring and hormonal therapy work for patients with ductal carcinoma in situ (DCIS), an early form of breast cancer. The main goal is to see if these methods can help manage the disease without immediate surgery. Participants will receive either standard hormonal therapy or investigational treatments and will be monitored with MRI scans at different points to check on their progress.
The trial's ID is NCT06075953. This is a Phase 2 trial, which means it is looking at how well the treatment works and its safety. It is FDA-regulated and aims to include around 400 participants.
Who can join
Women aged 18 and older who have been diagnosed with hormone receptor positive DCIS can join. Candidates include those who have had surgery with positive margins and have not had further surgery. Certain health conditions and recent treatments may affect eligibility. The trial team will confirm if you can participate.
Condition
Ductal Carcinoma in Situ
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly assigned to different treatment groups. They may receive one of three investigational medications, or standard hormonal therapy. Everyone will go for MRI scans at 3 and 6 months, and then every 6 months after that. If surgery is needed based on evaluation, participants will stop the study treatment and undergo surgery instead. Blood and saliva samples will also be collected for research.
Where
This trial is running at 28 locations in the United States. 25 of them are currently recruiting.
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina
Berkeley Outpatient Center
Berkeley, California
City of Hope
South Pasadena, California
City of Hope - Lennar Foundation Cancer Center
Irvine, California
City of Hope -Duarte Cancer Center
Duarte, California
Duke Cancer Institute
Durham, North Carolina
Englewood Hospital and Medical Center
Englewood, New Jersey
Health Partners - Frauenshuh Cancer Center
Saint Louis Park, Minnesota
The first 8 of 28 sites are listed here. The registry record has the full list.