About this trial
This study looks at how well the medicine sacituzumab govitecan-hziy (SG) combined with pembrolizumab works for patients with triple negative breast cancer. These are patients who still have cancer after surgery and treatment before surgery. Researchers want to see if this combination is better than the treatment chosen by their doctor, which may include pembrolizumab alone or with capecitabine.
The trial's ID number is NCT05633654. This is a Phase 3 trial, which means it is looking at the effectiveness and safety of the treatments. It is regulated by the FDA, and the study hopes to include about 1,514 participants.
Who can join
Participants must be 18 years or older. They should have triple negative breast cancer that remains after treatment. They must also be recovering well from surgery and have good overall health. Some people, like those with advanced cancer or certain heart conditions, cannot join. The trial team will confirm who is eligible.
Condition
Triple Negative Breast Cancer
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Everyone in this study will be placed into one of two groups by chance. One group will receive sacituzumab govitecan-hziy and pembrolizumab for up to 8 cycles. The other group will receive a treatment chosen by their doctor, which could be pembrolizumab alone or with capecitabine. Treatments will continue unless there is a return of cancer or other reasons to stop.
Where
This trial is running at 184 locations in the United States. 122 of them are currently recruiting.
Alabama Oncology
Birmingham, Alabama
Alta Bates Summit Medical Center
Berkeley, California
Anita Stewart Oncology Center
Columbus, Ohio
Ascension St. Francis Reiman Cancer Center
Franklin, Wisconsin
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina
Avera Cancer Institute
Sioux Falls, South Dakota
Baptist Clinical Research Institute
St Louis, Missouri
Beth Israel Deaconess Medical Center
Boston, Massachusetts
The first 8 of 184 sites are listed here. The registry record has the full list.