A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

简要总结

主要结局

次要结局

• Overall Survival (OS)(From randomization to death from any cause (up to 7 years))
• Investigator-assessed Objective Response Rate (ORR)(Up to 7 years)
• Investigator-assessed Duration of Response (DOR)(From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years))
• Investigator-assessed Clinical Benefit Rate (CBR)(Up to 7 years)
• Time to Confirmed Deterioration (TTCD) in Pain(From baseline until end of follow-up (up to 7 years))
• TTCD in Physical Function(From baseline until end of follow-up (up to 7 years))
• TTCD in Role Function(From baseline until end of follow-up (up to 7 years))
• TTCD in Global Health Status(From baseline until end of follow-up (up to 7 years))
• Percentage of Participants with Adverse Events(From baseline until end of follow-up (up to 7 years))
• Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Up to 7 years)
• Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G)(Up to 7 years)
• Change from Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE(Baseline up to 7 years)
• Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item(Baseline up to 7 years)