This study focuses on treating hormone receptor-positive, HER2-negative, PIK3CA mutated, locally advanced or metastatic breast cancer that has progressed during or after previous treatments. The study compares two treatment combinations: inavolisib plus fulvestrant versus alpelisib plus fulvestrant. These medications belong to a class of drugs called kinase inhibitors that work by blocking specific proteins involved in cancer growth.
The main purpose of this research is to determine how well inavolisib combined with fulvestrant works compared to alpelisib combined with fulvestrant in treating this specific type of breast cancer. The study will measure how long patients live without their cancer getting worse. Other aspects being studied include overall survival time, how well tumors respond to treatment, and how the treatments affect patients’ quality of life.
Participants will receive either inavolisib or alpelisib pills taken by mouth daily, along with fulvestrant given as an intramuscular injection. During the study, patients will have regular medical check-ups and tests to monitor their cancer and any side effects from the treatment. The effectiveness of the treatment will be assessed through various medical examinations and imaging tests.



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