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
Summary
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).
Arms & interventions
- DrugInavolisib
Inavolisib will be administered as per the schedule mentioned in the protocol.
- DrugRibociclib
Ribociclib will be administered as per the schedule mentioned in the protocol.
- DrugFulvestrant
Fulvestrant will be administered as per the schedule mentioned in the protocol.
- DrugPlacebo
Placebo will be administered as per the schedule mentioned in the protocol.
Outcome measures
Primary
Percentage of Participants With Confirmed Objective Response (cORR)
Time frame: Up to approximately 2 years
Secondary
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
Eligibility criteria
Study locations (6)
Avera Cancer Institute - Marshall
Marshall, Minnesota, 56258
Avera Cancer Institute - Aberdeen
Aberdeen, South Dakota, 57401
Avera Cancer Institute - Mitchell
Mitchell, South Dakota, 57301
Avera Cancer Institute - Pierre, SD
Pierre, South Dakota, 57501
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
AMG Oncology and Hematology Avera Cancer Institute - Yankton
Yankton, South Dakota, 57078