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A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
NCT06790693 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Letrozole
- DRUG Inavolisib
- DRUG CDK4/6i
Study Locations (20)
California
- Disney Family Cancer Center — Burbank
- Scripps Health — La Jolla
- Cancer and Blood Specialty Clinic — Los Alamitos
- Ellison Institute of Technology — Los Angeles
- Palo Alto Medical Foundation Research Center — Palo Alto
- Kaiser Permanente - San Marcos — San Marcos
- Palo Alto Medical Foundation Research Center — San Mateo
- Palo Alto Medical Foundation Research Center — Sunnyvale
Kentucky
- Baptist Health Lexington — Lexington
- Baptist Health Hamburg — Lexington
- University of Kentucky - Markey Cancer Center — Lexington
- Baptist Health Louisville — Louisville
Illinois
- Cancer Care Specialists of Central Illinois — O'Fallon
- Springfield Clinic — Springfield
- Carle Cancer Center — Urbana
Florida
- Tallahassee Memorial HealthCare — Tallahassee
- Moffitt Cancer Center-McKinley Campus — Tampa
Georgia
- Northwest Georgia Oncology Centers PC - Marietta — Marietta
Maryland
- Velocity Clinical Research — Annapolis
Michigan
- Henry Ford Health System — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2025-04-09 |
| Est. Completion | 2032-05-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06790693
The ClinicalTrials.gov registry entry for NCT06790693 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06790693 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Kentucky, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06790693 about?
NCT06790693 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer". 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-po...
What is the current status of trial NCT06790693?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2025-04-09. Estimated completion is 2032-05-30.
What conditions does trial NCT06790693 study?
This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06790693?
The interventions under investigation include: Placebo (DRUG), Letrozole (DRUG), Inavolisib (DRUG), CDK4/6i (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06790693?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06790693 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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