A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

This study is testing a new way to treat certain types of advanced breast cancer that have stopped responding to previous therapies. Researchers want to see if combining a new medication, inavolisib, with a standard hormone therapy called fulvestrant is safe and effective at stopping cancer growth.

You may be eligible if you have HR-positive, HER2-negative breast cancer that has a specific genetic change called a PIK3CA mutation. This study is for people whose cancer progressed after one prior hormone-based treatment and who do not currently need chemotherapy.

Participants will receive a combination of inavolisib and fulvestrant to help block signals that allow cancer cells to grow. Throughout the study, you will have regular check-ups and medical imaging, like CT or MRI scans, so doctors can monitor your health and how well the treatment is working.

This study is currently recruiting volunteers at locations in Los Angeles, California; Jacksonville, Florida; and East Brunswick, New Jersey. Please reach out to your oncology team to see if one of these centers is a good fit for you.