A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with chromosome 8p loss (chr8p loss) and without PIK3CA mutation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Inavolisib will be administered as per the schedule mentioned in the protocol.
Ribociclib will be administered as per the schedule mentioned in the protocol.
Fulvestrant will be administered as per the schedule mentioned in the protocol.
Placebo will be administered as per the schedule mentioned in the protocol.
McGill University
Montreal, Quebec, Canada
Percentage of Participants With Confirmed Objective Response (cORR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Percentage of Participants with Clinical Benefit (CBR)
Time frame: Up to approximately 2 years
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 2 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)
Time frame: Up to approximately 2 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)
Time frame: Up to approximately 2 years
Change From Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE
Time frame: Baseline, Up to approximately 2 years
Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item
Time frame: Baseline, Up to approximately 2 years
Reference Study ID Number: CO46274 https://forpatients.roche.com/
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