This trial is looking at two different treatment combinations for patients with a type of breast cancer that has specific mutations. It focuses on women and men with hormone receptor positive, HER2 negative breast cancer that has come back or progressed after earlier treatments. The goal is to see which treatment works better and is safer for these patients.
This is a Phase 3 trial, which means it is looking at how well the treatments work and how safe they are. The trial will include about 540 participants and is regulated by the FDA.
Who can join
Adults aged 18 and older can participate. Both men and women can join. Participants must have a specific type of breast cancer with a PIK3CA mutation and have had certain previous treatments. The trial team will check to confirm who can join.
Conditions
PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
Age group
Adult, Older adult
Sex
All sexes
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 a combination of RLY-2608 and fulvestrant, while the other group will get capivasertib and fulvestrant. Both treatments are given alongside fulvestrant, which is an injection. The study is designed to find out how well each treatment works.
Where
This trial is enrolling at 51 locations. Recruiting sites are listed first.
Inaugural Jeffrey F. Moley Professor of Endocrine and Oncologic Surgery, WashU. Treats breast cancer. Works as a surgical oncologist. Based in St. Louis, Missouri. Chosen on merit.
Microsurgical breast reconstruction specialist, MSK. Treats breast cancer and mouth cancer. Offers microsurgical breast reconstruction, head and neck reconstruction and abdominal wall reconstruction. Works as a plastic & reconstructive surgeon. Based in New York. Chosen on merit.