A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib plus Ribociclib plus Fulvestrant Versus Placebo plus Ribociclib plus Fulvestrant in Patients with Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8P Loss and Without a PIK3CA Mutation

Condition studied

Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8p Loss and Without PIK3CA Mutation

Investigational medicinal product(s)

Eligibility

Primary endpoint

Investigator-Assessed Confirmed ORR

Endpoint detail

PFS, OS, Investigator-assessed DOR, Investigator-assessed CBR, Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), Change from baseline in targeted vital signs, Change from baseline in targeted clinical laboratory test results, Presence, frequency of occurrence, severity, and/or degree of interference with daily activities of symptomatic treatment toxicities as assessed through use of the National Cancer Institute (NCI) Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument, Proportion of participants reporting each response option at each assessment timepoint by treatment arm for treatment side-effect bother single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General questionnaire (FACT-G), Change from baseline/worsening in symptomatic treatment toxicities and treatment side-effect bother as assessed through use of the PRO-CTCAE and FACT-G GP5 item, respectively