A Phase 3 interventional study of Inavolisib and Placebo in Breast Cancer, sponsored by Hoffmann-La Roche. Recruiting at 242 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 450 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive inavolisib, letrozole and CDK4/6i.
Drug: Inavolisib · Drug: CDK4/6i · Drug: Letrozole
Participants will receive placebo, letrozole and CDK4/6i.
Drug: Placebo · Drug: CDK4/6i · Drug: Letrozole
Participants will receive oral inavolisib once daily (QD).
Also known as: GDC-0077, Itovebi
Participants will receive oral placebo QD.
Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
Participants will receive oral letrozole QD.
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
Showing the first 100 of 242 sites across 20 countries.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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