fulvestrant achieved a median progression-free survival (PFS)
The randomized, double-blind, placebo-controlled trial enrolled 325 adult patients with endocrine resistant, PIK3CA-mutated, hormone receptor–positive, HER2-negative breast cancer that was locally advanced or metastatic.2 Patients were required to have experienced disease progression during or within 12 months of completing adjuvant endocrine therapy. Prior receipt of systemic therapy for locally advanced or metastatic disease was not permitted.
Upon enrollment, patients were randomly assigned 1:1 to receive either 9 mg of oral inavolisib or placebo once daily during a 28-day cycle. This was administered alongside 125 mg of daily palbociclib for 21 days per cycle and 500 mg of fulvestrant administered intramuscularly on days 1 and 15 of cycle 1, and day 1 of each subsequent cycle. Treatment continued until disease progression or unacceptable toxicity.
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