Treatment
toxicity
ADVERSE EVENTS, DISEASE PROGRESSION, METASTASIS
Patients were randomised 1:1 to receive an intravenous infusion of xentuzumab (1000 mg/week) or placebo in combination with everolimus (10 mg/day orally) and exemestane (25 mg/day orally). Randomisation was stratified by the presence of baseline bone-only metastasis (yes vs no) and prior CDK4/6 inhibitor treatment (yes vs no). Dose reduction of xentuzumab was not permitted; however, treatment could be paused for up to 14 days for resolution of adverse events (AEs). Everolimus and exemestane treatment was administered in accordance with their respective Summary of Product Characteristics, Monograph or Prescribing Information (allowing dose interruption and adjustment for everolimus). Treatment continued until disease progression, unacceptable toxicity or other reasons requiring treatment discontinuation.