Phase II Study Comparing Two Dose Levels of Inavolisib Combined With Fulvestrant in Patients With PIK3CA-Mutated, HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

What this Trial Is About

This trial investigates the efficacy and safety of inavolisib combined with fulvestrant in adults with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have previously been treated with a cyclin-dependent kinase inhibitor. The study compares two different doses of inavolisib given with fulvestrant in this specific group of patients to assess treatment outcomes. Participants receive oral inavolisib tablets alongside intramuscular injections of fulvestrant. The study is randomized and open-label, with two experimental groups receiving different doses of inavolisib plus fulvestrant. Treatment and assessments continue for up to approximately two years to evaluate various outcomes. During the study, participants will undergo regular assessments including tumor response evaluations, safety monitoring for adverse events, and patient-reported outcomes on treatment side effects and quality of life. Researchers will track objective response rates, duration and time to response, progression-free survival, treatment discontinuations due to side effects, and symptom changes over time. The total participation may last up to five years, including follow-up assessments after primary treatment completion.

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer