This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
Participants will receive oral inavolisib once daily (QD).
Participants will receive oral placebo QD.
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Participants will receive oral letrozole QD.
Disney Family Cancer Center
Burbank, California, United States
RECRUITINGScripps Health
La Jolla, California, United States
RECRUITINGCancer and Blood Specialty Clinic
Los Alamitos, California, United States
RECRUITINGEllison Institute of Technology
Los Angeles, California, United States
Progression-Free Survival (PFS)
Time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)
Overall Survival (OS)
Time frame: From randomization to death from any cause (up to 7 years)
Investigator-assessed Objective Response Rate (ORR)
Time frame: Up to 7 years
Investigator-assessed Duration of Response (DOR)
Time frame: 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)
Time frame: Up to 7 years
Time to Confirmed Deterioration (TTCD) in Pain
Time frame: From baseline until end of follow-up (up to 7 years)
TTCD in Physical Function
Time frame: From baseline until end of follow-up (up to 7 years)
TTCD in Role Function
Time frame: From baseline until end of follow-up (up to 7 years)
TTCD in Global Health Status
Time frame: From baseline until end of follow-up (up to 7 years)
Percentage of Participants with Adverse Events
Time frame: 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)
Time frame: 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)
Time frame: Up to 7 years
Change from Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE
Time frame: Baseline up to 7 years
Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item
Time frame: Baseline up to 7 years
Reference Study ID Number: WO45654 https://forpatients.roche.com/
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Palo Alto Medical Foundation Research Center
Palo Alto, California, United States
RECRUITINGKaiser Permanente - San Marcos
San Marcos, California, United States
RECRUITINGPalo Alto Medical Foundation Research Center
San Mateo, California, United States
RECRUITINGPalo Alto Medical Foundation Research Center
Sunnyvale, California, United States
RECRUITINGTallahassee Memorial HealthCare
Tallahassee, Florida, United States
RECRUITINGMoffitt Cancer Center-McKinley Campus
Tampa, Florida, United States
RECRUITING...and 194 more locations