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NCT06790693 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT06790693 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 450 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT06790693, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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.
NCT06790693 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Kentucky, Illinois.
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.
What interventions are being tested in trial NCT06790693?
The interventions under investigation include: Placebo (DRUG), Letrozole (DRUG), Inavolisib (DRUG), CDK4/6i (DRUG).
Who is sponsoring clinical trial NCT06790693?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.